Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes (ABOH-PS)

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ClinicalTrials.gov Identifier: NCT04920552

Recruitment Status : Recruiting

First Posted : June 10, 2021

Last Update Posted : June 10, 2021

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Sponsor:

Information provided by (Responsible Party):

Gregor Wenning, Universitätsklinik für Neurologie, Innsbruck

Study Description

Brief Summary:

The purpose of the present clinical trial is to determine whether the use of an elastic abdominal binder is effective in the non-pharmacological management of symptomatic, neurogenic orthostatic hypotension (OH) in individuals suffering from Parkinson's disease (PD) or Parkinson variant multiple system atrophy (MSA-P).

Condition or disease	Intervention/treatment	Phase
Parkinson Disease Multiple System Atrophy, Parkinson Variant Orthostatic; Hypotension, Neurogenic	Device: Elastic abdominal binder Device: Placebo binder	Not Applicable

Detailed Description:

This is a monocentric, randomized, placebo-controlled, double-blind, crossover phase II clinical trial with an open-label treatment extension phase. The investigators plan to recruit n = 30 individuals with MSA-P or PD with known or suspected OH.

At the Screening Visit, after patient information and written informed consent, the participants will first undergo a comprehensive neurological and cardiological evaluation, as well cardiovascular autonomic function testing to confirm the diagnosis of symptomatic, neurogenic OH.

Afterwards, the participants will be asked to wear physical activity monitoring (PAM) sensors for five consecutive days and to measure the blood pressure (BP) regularly following a home BP diary (i.e. Home Phase I).

On treatment day-1 (i.e. Visit 1), the participants will undergo an instrumented in-lab gait analysis, followed by a head-up tilt and active standing test. Afterwards, they will wear the first type of binder for two hours (either the investigational elastic abdominal binder or the placebo-comparator binder, depending on the randomization assignment). At the end of the two hours, the participants will repeat the in-lab gait analysis and the head-up tilt-/active standing test.

After one-day wash-out, the same procedure of treatment day-1 (i.e. Visit 1) will be repeated with the outstanding type of binder (i.e. treatment day-2, Visit 2).

At the end of this, all participants will be invited to wear the investigational elastic abdominal binder and the PAM sensors for five more days and to repeat the home BP measurements (i.e. Home Phase II).

A final follow-up visit is scheduled to return the PAM sensors, the BP monitor and to detect eventual adverse and serious adverse events occurred during Home Phase II.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Intervention Model Description:	monocentric, randomized, placebo-controlled, double-blind, crossover phase II trial with an open-label treatment extension phase
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes: a Randomized, Placebo-controlled, Double-blind, Crossover Phase II Trial
Actual Study Start Date :	May 17, 2021
Estimated Primary Completion Date :	November 2023
Estimated Study Completion Date :	November 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Perry syndrome Multiple system atrophy Orthostatic hypotension Parkinson disease

MedlinePlus related topics: Low Blood Pressure

Genetic and Rare Diseases Information Center resources: Multiple System Atrophy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo binder first Participants in this arm will wear the placebo comparator ("Clima Care" body warmer, Bort Medical GmbH) for 2 hours on treatment day-1 (i.e. Visit 1), followed by the active comparator ("ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH) for 2 hours on treatment day-2 (i.e. Visit 2).	Device: Elastic abdominal binder The "ABDO-SYNCRO 3-BAHNIG" is an elastic abdominal binder with a 3-stripes Velcro fastening, capable of developing a 20 ± 2 mmHg pressure on the abdominal wall. This device will be tested as potentially beneficial with respect to the mentioned primary and secondary outcomes. The investigators anticipate to use this elastic abdominal binder, since participants of a previous trial reported this device to be comfortable enough and to have used it regularly during the open-label follow-up phase. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer (SYNCRO-MED GmbH). Other Name: "ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH Device: Placebo binder "Clima Care" is a simple body warmer, developing maximal 3±2 mmHg pressure on the abdominal wall. This device will be used as placebo comparator of the present clinical trial. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer. Other Name: "Clima Care" body warmer, Bort Medical GmbH
Active Comparator: Elastic abdominal binder first Participants in this arm will wear the active comparator ("ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH) for 2 hours on treatment day-1 (i.e. Visit 1), followed by the placebo comparator ("Clima Care" body warmer, Bort Medical GmbH) for 2 hours on treatment day-2 (i.e. Visit 2).	Device: Elastic abdominal binder The "ABDO-SYNCRO 3-BAHNIG" is an elastic abdominal binder with a 3-stripes Velcro fastening, capable of developing a 20 ± 2 mmHg pressure on the abdominal wall. This device will be tested as potentially beneficial with respect to the mentioned primary and secondary outcomes. The investigators anticipate to use this elastic abdominal binder, since participants of a previous trial reported this device to be comfortable enough and to have used it regularly during the open-label follow-up phase. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer (SYNCRO-MED GmbH). Other Name: "ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH Device: Placebo binder "Clima Care" is a simple body warmer, developing maximal 3±2 mmHg pressure on the abdominal wall. This device will be used as placebo comparator of the present clinical trial. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer. Other Name: "Clima Care" body warmer, Bort Medical GmbH

Arm

Intervention/treatment

Placebo Comparator: Placebo binder first

Participants in this arm will wear the placebo comparator ("Clima Care" body warmer, Bort Medical GmbH) for 2 hours on treatment day-1 (i.e. Visit 1), followed by the active comparator ("ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH) for 2 hours on treatment day-2 (i.e. Visit 2).

Device: Elastic abdominal binder

The "ABDO-SYNCRO 3-BAHNIG" is an elastic abdominal binder with a 3-stripes Velcro fastening, capable of developing a 20 ± 2 mmHg pressure on the abdominal wall. This device will be tested as potentially beneficial with respect to the mentioned primary and secondary outcomes. The investigators anticipate to use this elastic abdominal binder, since participants of a previous trial reported this device to be comfortable enough and to have used it regularly during the open-label follow-up phase. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer (SYNCRO-MED GmbH).

Other Name: "ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH

Device: Placebo binder

"Clima Care" is a simple body warmer, developing maximal 3±2 mmHg pressure on the abdominal wall. This device will be used as placebo comparator of the present clinical trial. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer.

Other Name: "Clima Care" body warmer, Bort Medical GmbH

Active Comparator: Elastic abdominal binder first

Participants in this arm will wear the active comparator ("ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH) for 2 hours on treatment day-1 (i.e. Visit 1), followed by the placebo comparator ("Clima Care" body warmer, Bort Medical GmbH) for 2 hours on treatment day-2 (i.e. Visit 2).

Device: Elastic abdominal binder

Other Name: "ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH

Device: Placebo binder

Other Name: "Clima Care" body warmer, Bort Medical GmbH

Outcome Measures

Primary Outcome Measures :

Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]

Secondary Outcome Measures :

Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 3rd minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 [Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 10th minute of head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 [Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 3rd minute of active standing test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 3rd minute of active standing test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 3rd minute of active standing test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 3rd minute of active standing test with respect to baseline. [ Time Frame: 3 days ]
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 [Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine mean BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine systolic BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine diastolic BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine mean BP value (mmHg) at 5th minute before active standing test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine systolic BP value (mmHg) at 5th minute before active standing test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine diastolic BP value (mmHg) at 5th minute before active standing test with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on in-lab sensor-based mean gait velocity with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on in-lab sensor-based mean stride length with respect to baseline. [ Time Frame: 3 days ]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on lowest systolic BP values (mmHg) after 3rd minute of home active standing test in the early morning. [ Time Frame: 10 days ]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on lowest systolic BP values (mmHg) after 3rd minute of home active standing test 60 minutes after lunch. [ Time Frame: 10 days ]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on highest supine systolic BP values (mmHg) at 5th minute before home active standing test in the evening. [ Time Frame: 10 days ]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on OH symptom severity. [ Time Frame: 10 days ]
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" [Range: 0 (minimum, i.e. "no symptoms") to 100 (maximum, i.e. "worst possible symptoms")], including subcales "Orthostatic Hypotension Symptom Assessment" [Range: 0 (minimum, i.e. "no symptoms") to 60 (maximum, i.e. "worst possible symptoms")] and "Orthostatic Hypotension Daily Activitiy Scale" [Range: 0 (minimum, i.e. "no interference") to 40 (maximum, i.e. "total interference")], as well as single-item scores [Range: 0 (minimum, i.e. "no symptoms/interference") to 10 (maximum, i.e. "worst possible symptoms/total interference")]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on overall mobility. [ Time Frame: 10 days ]
Overall mobility measured by the International Physical Activity Questionnaire (IPAQ), indicated in total physical activity metabolic equivalent minutes per week (i.e. total MET-minutes/week) [Range: 0 (minimum, i.e. "no physical activity"), no maximum (i.e. the higher the better the overall mobility)]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived number of walking bouts. [ Time Frame: 10 days ]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived duration of walking bouts. [ Time Frame: 10 days ]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived mean gait velocity. [ Time Frame: 10 days ]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived mean stride length. [ Time Frame: 10 days ]
Number of participants with treatment-related adverse events. [ Time Frame: 8 days ]
Adverse event rates will be coded by body system and MedDRA classification terms. Adverse events will be tabulated by treatment group and will include the number of participants for whom the event occurred, the rate of occurrence, the severity and relationship to the investigational medical device.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of possible or probable MSA-P (Gilman 2008) or clinically established PD (Postuma 2015);
50 to 80 years of age;
laboratory-confirmed symptomatic (i.e. OHQ - OH Symptom Assessment item #1 ≥ 4), neurogenic OH at screening visit or previously diagnosed as such (i.e. neurogenic OH ratio [≤ 0.492 Δ heart rate rise/systolic BP fall] or missing BP overshoot at phase IV of Valsalva maneuver;
stable medication schedule in the preceding 3 weeks;
no infectious disease in the preceding 3 weeks;
Hoehn & Yahr stage ≤ 3;
gait item of the Unified MSA Rating Scale (UMSARS) Part II or the Movement Disorder Society - Unified PD Rating Scale (MDS-UPDRS) Part III score < 3;
body sway item of the UMSARS II/MDS-UPDRS III score < 3;
arising from chair item of the UMSARS II/MDS-UPDRS III score < 3;
full legal capacity;
written informed consent has been obtained.

Exclusion Criteria:

participation in other interventional trials;
prescribed and regular use of abdominal binders OR compression stockings for OH treatment;
other major neurologic or psychiatric diseases which could influence OH or gait;
untreated diabetes mellitus with clinical features of peripheral neuropathy;
non-neurological causes of gait disorders;
major cardiac diseases (ischemic, structural, arrhythmias);
evidence of varices (venous insufficiency stage ≥ C2, "varicose veins");
known abdominal aortic aneurism;
indwelling catheterisation;
recent surgery (3 months) requiring anaesthesia;
known or suspected pregnancy;
breast-feeding female participants.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04920552

Contacts

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Contact: Gregor K. Wenning, Prof. DDr. MSc	004351250481811	gregor.wenning@i-med.ac.at
Contact: Alessandra Fanciulli, DDr.	004351250483238	alessandra.fanciulli@i-med.ac.at

Locations

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Austria
Medical University Innsbruck	Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Gregor K. Wenning, Prof. DDr. MSc. 004351250481811 gregor.wenning@i-med.ac.at
Contact: Alessandra Fanciulli, DDr. 004351250483238 alessandra.fanciulli@i-med.ac.at

Sponsors and Collaborators

Universitätsklinik für Neurologie, Innsbruck

More Information

Publications:

Fanciulli A, Goebel G, Metzler B, Sprenger F, Poewe W, Wenning GK, Seppi K. Elastic Abdominal Binders Attenuate Orthostatic Hypotension in Parkinson's Disease. Mov Disord Clin Pract. 2015 Nov 27;3(2):156-160. doi: 10.1002/mdc3.12270. eCollection 2016 Mar-Apr.

Fanciulli A, Wenning GK. Multiple-system atrophy. N Engl J Med. 2015 Jan 15;372(3):249-63. doi: 10.1056/NEJMra1311488. No abstract available.

Fanciulli A, Leys F, Falup-Pecurariu C, Thijs R, Wenning GK. Management of Orthostatic Hypotension in Parkinson's Disease. J Parkinsons Dis. 2020;10(s1):S57-S64. doi: 10.3233/JPD-202036.

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Responsible Party:	Gregor Wenning, Head of Division of Neurobiology, Department of Neurology, Medical University of Innsbruck; Principle Investigator; Professor DDr. MD MSc, Universitätsklinik für Neurologie, Innsbruck
ClinicalTrials.gov Identifier:	NCT04920552
Other Study ID Numbers:	1483/2020
First Posted:	June 10, 2021 Key Record Dates
Last Update Posted:	June 10, 2021
Last Verified:	June 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Parkinson Disease Multiple System Atrophy Shy-Drager Syndrome Hypotension, Orthostatic Parkinsonian Disorders Hypotension Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases	Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Vascular Diseases Cardiovascular Diseases Primary Dysautonomias Autonomic Nervous System Diseases Orthostatic Intolerance

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