MotIoN aDaptive Deep Brain Stimulation for MSA

NCT05197816 | Completed DMC

• 1 other identifier: 20/LO/1034
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Patients routinely undergo deep brain stimulation (DBS) for treatment of symptoms related to neurodegenerative conditions, most commonly Parkinson's disease. In the Investigator's 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 effects on autonomic parameters such as blood pressure and bladder symptoms has been shown to be improved by the investigators (unpublished data). In this current study, the investigators plan to use a novel technique of adaptive DBS in order to provide stimulation dependent on patient physiological or positional factors. This is with the aim of making stimulation more responsive and patient-specific.

Conditions

MSA - Multiple System Atrophy

Keywords

deep brain stimulation; autonomic

Outcome Measures

Primary Outcomes (8)

• Change in quality of life before and after DBS measured by EuroQol-5 domains

  EQ-5D before and after DBS. Each domain score 1-5, higher is worse.

  Pre-operative and at 3 months after stimulation

• Change in freezing of gait before and after DBS, measured by freezing of gait questionnaire

  Measured by Freezing of gait questionnaire (FOG) before and after DBS, Score 0-24, higher is worse.

  Pre-operative and at 3 months after stimulation

• Change in the number of sleep arousals per night

  Measured by change in number of arousals on polysomnography before and after DBS

  Pre-operative and at 3 months after stimulation

• Change in Cardiovascular symptoms following DBS (continuous blood pressure)

  24 hour ambulatory blood pressure recorded pre \& 3 months post DBS

  Pre-operative and at 3 months after stimulation

• Change in Cardiovascular symptoms pre-post DBS (change in postural blood pressure)

  Measured by tilt table blood pressure, recorded pre \& 3 months post DBS

  Pre-operative and at 3 months after stimulation

• Change of power in alpha bands on polysomnography before and after DBS

  Measured by change in alpha bands on polysomnography before and after DBS

  Pre-operative and at 3 months after stimulation

• Change of power in beta bands on polysomnography before and after DBS

  Measured by change in beta bands on polysomnography before and after DBS

  Pre-operative and at 3 months after stimulation

• Change of power in gamma bands on polysomnography before and after DBS

  Measured by change in gamma bands on polysomnography before and after DBS

  Pre-operative and at 3 months after stimulation

Secondary Outcomes (7)

• Number of patients with treatment-related adverse events

  Throughout study up to 6 months

• Measurement of Falls frequency

  Throughout study up to 3 months

• Frequency and volume of bladder voiding before and after stimulation

  Pre-operative and at 3 months after stimulation

• Autonomic function before and after stimulation measured by autonomic symptom profile

  Pre-operative and at 3 months after stimulation

• Carer Burden before and after stimulation measured by Zarit Burden interview

  Pre-operative and at 3 months after stimulation

Study Arms (1)

Deep brain stimulation

EXPERIMENTAL

All patients will undergo adaptive deep brain stimulation with results compared before and after stimulation

Device: Deep brain stimulation

Interventions

Deep brain stimulation DEVICE

Electrical pulses from implanted generator that adapts to patient activity and/or physiology

Deep brain stimulation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of MSA with disabling autonomic symptoms
• \>6/12 in the autonomic subsection (Q9-12) of the UMSAR scale
• Patient willing and able to give informed consent to involvement in the study.
• Male or female aged 55 years or over
• Able to walk (to perform gait analysis)
• Have an anticipated prognosis \> 2 years

You may not qualify if:

• Female of child-bearing age
• The patient is unwilling to participate or unable to give informed consent.
• 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)
• Untreated anxiety or depression
• Unable to undergo preoperative MRI (e.g. metal implants)
• Subject is currently participating in a clinical investigation that includes an active treatment arm.

Sponsors & Collaborators

• University of Oxford: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Shy-Drager Syndrome

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluation of symptomatology "on" and "off" adaptive deep brain stimulation

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 20, 2022
• Study Start: December 3, 2021
• Primary Completion: March 4, 2025
• Study Completion: August 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-08

Locations

GB (1)