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Trial record 29 of 88 for:    "Brain Diseases" AND "Multiple System Atrophy"

Deep Brain Stimulation for Autonomic and Gait Symptoms in Multiple System Atrophy (STAG-MSA)

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ClinicalTrials.gov Identifier: NCT03593512
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Medical Research Council (UK)
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of symptoms related to neurodegenerative conditions, most commonly Parkinson's disease.

In the investigators experience, and published evidence shows, that stimulation has effects on the autonomic nervous system. In patients undergoing therapeutic DBS for a particular subtype of Parkinsonism, Multiple System Atrophy, the further effects on autonomic parameters such as blood pressure and bladder symptoms as well as the originally intended indications (gait and movement disorder) will be investigated. The mechanisms of any effects will also be studied by using a number of techniques such as magnetoencephalography (MEG) and Muscle Sympathetic Nerve Activity (MSNA) recording.

Key goals are to:

  1. Demonstrate that stimulation of the peduculopontine nucleus (PPN) improves autonomic function and has an attendant improvement on patients' quality of life
  2. Investigate the role of the PPN and how it interacts with other brain areas.

This translational strategy will lead to a larger efficacy study of DBS for MSA as well as revolutionizing neural-based treatments in other autonomic disorders such as orthostatic hypotension and pure autonomic failure.


Condition or disease Intervention/treatment Phase
Multiple System Atrophy Autonomic Failure Postural Hypotension Bladder, Neurogenic Gait Disorders, Neurologic Procedure: Deep brain stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Evaluation of symptomatology before and after implantation of DBS electrodes; followed by cross-over of "on" and "off" stimulation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for Autonomic and Gait Symptoms in Multiple System Atrophy
Actual Study Start Date : September 9, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: PPN DBS
All patients will undergo bilateral PPN DBS
Procedure: Deep brain stimulation
Bilateral deep brain stimulation of the pedunculopontine nucleus




Primary Outcome Measures :
  1. EuroQol 5 Dimension (5 level) score before and after deep brain stimulation [ Time Frame: Through study completion, but on average, over an 8 month period for each patient ]
    Measurement of quality of life before and after surgery. Results will be given as description of health states - it is not quantitative.

  2. Fluency of gait as measured by accelerometry before and after deep brain stimulation [ Time Frame: Through study completion, but on average, over an 8 month period for each patient ]
    Measurement of gait parameters before and after surgery

  3. Modified composite autonomic symptom scale before and after deep brains stimulation [ Time Frame: Through study completion, but on average, over an 8 month period for each patient ]
    Measurement of autonomic symptomatology before and after surgery - Score from 0-100

  4. Change in postural blood pressure change before and after PPN DBS [ Time Frame: Through study completion, but on average, over an 8 month period for each patient ]
    Measurement of effect on postural blood pressure change before and after surgery


Secondary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as Assessed by using approved UK reporting procedure [ Time Frame: Through study completion, 2 years ]
    To assess the safety of PPN DBS on MSA patients by recording adverse events

  2. Muscle sympathetic nerve activity before and after deep brain stimulation [ Time Frame: Through study completion, but on average, over an 8 month period for each patient ]
    To determine whether or not PPN suppression or excitation alters sympathetic outflow by measuring the activity in autonomic nerves in the leg

  3. Cortical magentoencephalography profile with deep brain stimulation on and off [ Time Frame: 3-6 months after surgery ]
    Identification in change of cortical magetic activity with DBS on and off

  4. Physical anatomical white matter connections between the pedunculopontine nucleus and the rest of the central nervous system [ Time Frame: Before surgery and 3-6 months after surgery ]
    To identify the physical anatomical relations of the stimulated region of brain by looking at high resolution structural imaging studies



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

Inclusion Criteria:

  1. Diagnosis of MSA with disabling autonomic symptoms (bladder dysfunction and orthostatic symptoms
  2. UMSARS score of >40
  3. >6/12 in the autonomic subsection (Q9-12) of the UMSAR scale
  4. Patient willing and able to give informed consent to involvement in the study.
  5. Male or female, aged 18 years or over.
  6. Able to walk unaided (to perform gait analysis)
  7. Have an anticipated prognosis > 2 years

Exclusion Criteria:

  1. The patient is unwilling to participate or unable to give informed consent.
  2. The patient has been deemed unfit for stimulator insertion by their healthcare team i.e. surgical contraindications to DBS:

    • Bleeding or coagulation disorder
    • Not fit for general anaesthetic
    • Unable to deal with implanted DBS system (turn on and off and recharging where applicable, although it is acceptable if a carer can do this)
  3. Untreated anxiety or depression
  4. Unable to undergo MRI (eg. metal implants)
  5. Subject is currently participating in a clinical investigation that includes an active treatment arm.
  6. Female who is pregnant - testing will be offered to female patients who are unsure.

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): NCT03593512


Contacts
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Contact: Sean C Martin, MRCS(Eng) 00441865234605 sean.martin@nds.ox.ac.uk
Contact: Alexander L Green, FRCS(SN) 00441865234605 alex.green@nds.ox.ac.uk

Locations
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United Kingdom
John Radcliffe Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Sean C Martin       sean.martin@nds.ox.ac.uk   
Contact: Alexander L Green       alex.green@nds.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
Medical Research Council (UK)
Investigators
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Principal Investigator: Alex L Green, FRCS(SN) University of Oxford

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03593512     History of Changes
Other Study ID Numbers: 13340
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are recruiting only 10 patients, so sharing IPD even anonymised, may be identifiable. Decision will be taken when this can be definitively elucidated.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Oxford:
multiple system atrophy
autonomic

Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Atrophy
Hypotension
Pure Autonomic Failure
Nervous System Diseases
Gait Disorders, Neurologic
Urinary Bladder, Neurogenic
Hypotension, Orthostatic
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Orthostatic Intolerance