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Trial record 10 of 981 for:    scale | Norway

A Controlled Comparison of Two DBS Targets for Upper Extremity Action Tremor (Tremorstim)

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ClinicalTrials.gov Identifier: NCT03156517
Recruitment Status : Enrolling by invitation
First Posted : May 17, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Inger Marie Skogseid, Oslo University Hospital

Brief Summary:

Action tremor of the arms can be an invalidizing symptom of diseases such as Essential Tremor, Dystonic Tremor, Parkinson's disease and Multiple Sclerosis. In this study we compare the efficacy and safety of two different brain targets for deep brain stimulation (DBS) that both are known to reduce action tremor of the arms. These two targets are called the VIM nucleus of the thalamus (VIM) and the posterior subthalamic area (PSA), which includes the Zona Incerta. Both targets can be reached by one lead (wirh four electrode contact).

Patients that are found eligible for DBS because of severe action tremor of the arms are invited to participate. After randomization, half of them are stimulated first in the VIM for 3 months and then in the PSA for 3 months, and the other half first in the PSA and then VIM for 3 months each. Tremor severity is scored on a clinical quantitative scale at baseline and at the end of each of these two 3-month periods, and eventual side-effects are registered. The best target is then selected and after another 6 months scoring is repeated. We intend to provide robust data about whether one of the two targets is superior to the other both regarding ability to reduce tremor efficiently and to avoid or minimize side-effects, or if there is no significant difference between the two targets. We also carefully check the exact position of the active electrode contact in the brain and compare this with efficacy and safety evaluations.


Condition or disease Intervention/treatment Phase
Action Tremor Device: Deep Brain Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized allocation of half the patients to be stimulated the first 3 months in the VIM-nucleus of the thalamus (VIM) and then 3 months in the posterior subthalamic area (PSA), and for the other half the first 3 months in the PSA and the next 3 months in the VIM
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The doctor who assesses the primary outcome measures at 3 and 6 months and the participant are both unaware of which of the two targets is stimulated in the two randomization periods.
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation in Disabling Action Tremor: A Randomized, Double-blind Study Comparing the Ventral Intermediate Nucleus (VIM) of the Thalamus and the Posterior Subthalamic Area (PSA) / Zona Incerta (The TREMORSTIM Study)
Actual Study Start Date : April 20, 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Active Comparator: Deep Brain Stimulation in VIM
Patients receive stimulation in the VIM-nucleus of the thalamus
Device: Deep Brain Stimulation
Active Comparator: Deep Brain Stimulation in PSA
Patients receive stimulation in the posterior subthalamic area
Device: Deep Brain Stimulation



Primary Outcome Measures :
  1. Upper extremity FTM-Tremor Rating Scale score change with VIM versus PSA-stimulation [ Time Frame: 3 months (+/- 2 weeks) and 6 months (+/- 2 weeks) after operation ]
    The difference in the change from baseline to the end of each of the two 3-month randomized cross-over periods, in tremor of the contralateral upper limb(s), as evaluated by items 5,6,10-14 and 16-21 in the Fahn-Tolosa-Marin (FTM)-score with VIM- versus PSA-stimulation.

  2. Other body regions FTM-Tremor Rating Scale score change with VIM versus PSA stimulation [ Time Frame: 3 months (+/- 2 weeks) and 6 months (+/- 2 weeks) after operation ]
    2) The difference in the change from baseline to the end of each of the two 3-month cross-over periods in the items scoring tremor of face/tongue/voice/trunk/lower limb(s), with VIM- versus PSA-stimulation.


Secondary Outcome Measures :
  1. FTM-Tremor rating Scale score changes from baseline to 1-yr (all body regions) [ Time Frame: 1 year (+/- 4 weeks) after surgery ]
    Change from baseline to 1-yr with stimulation at the most optimal of 4 electrode contacts of each patient (selected after the second randomization period) of the total FTM-score, tremor of the upper limb(s) (same items as above) and of the items scoring tremor in the face, tongue, voice, trunk, lower limb(s).

  2. Change of patient evaluated scores at 1 year of stimulation (QUEST and VAS Global Burden Disease Burden (Tremor-burden) [ Time Frame: 1 year (+/- 4 weeks) after surgery ]
    Change from baseline to 1-yr of Quality of Life in Essential Tremor (QUEST) scale, and Visual Analogue Scale of Global Disease Burden as assessed by the patient.

  3. Frequency of serious adverse events [ Time Frame: Comparing the two randomization periods (;at 3 and 6 months), and up to 1 year of stimulation ]
    Frequency of serious adverse events (surgical complications and stimulation related side-effects), including eventual deterioration on neuropsychological testing , registered during the first year of stimulation.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Min 5-yr duration chronic action tremor of upper limb(s), w/ or w/out tremor of head/neck, trunk, lower limbs, who have insufficient relief from adequate trials of recommended medications. The arm tremor must be so severe that it interferes with the patient's work performance or activities of daily living, such as drinking/eating, dressing/hygiene, and/or writing. Clinical diagnosis (according to criteria defined by the Consensus Statement of the Movement Disorders Society) include Essential Tremor, Dystonic Tremor, Cerebellar Tremor- idiopathic or secondary (to e.g.MS or SCA), or severe PD tremor (who are not eligible for DBS of the subthalamic nucleus).

Exclusion Criteria:

  • Brain MRI showing so marked general atrophy, or supra-tentorial white matter changes, that the safety of the procedure is affected. Co-morbidity of dementia or other severe neuropsychiatric disorder (major depression or anxiety disorder, active/recent psychosis, drug or other substance abuse). Increased risk of bleeding, cancer at advanced/not stabilized stage, other severe co-morbidity (e.g. With chronic pain, short life expectancy,). Other surgical contraindications.

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): NCT03156517


Locations
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Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Investigators
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Study Director: Inger Marie Skogseid, MDPhD Oslo University Hospital

Additional Information:
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Responsible Party: Inger Marie Skogseid, Consultant, MDPhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03156517     History of Changes
Other Study ID Numbers: 2013/1013
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Inger Marie Skogseid, Oslo University Hospital:
Treatment
Deep Brain Stimulation
VIM Nucleus of the Thalamus
Posterior Subthalamic Area
Zona Incerta
Efficacy
Safety

Additional relevant MeSH terms:
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Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms