MotIoN aDaptive Deep Brain Stimulation for MSA (NCT05197816) | Clinical Trial Compass
CompletedNot Applicable
MotIoN aDaptive Deep Brain Stimulation for MSA
United Kingdom3 participantsStarted 2021-12-03
Plain-language 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on autonomic parameters such as blood pressure and bladder symptoms has been shown to be improved by the investigators (unpublished data).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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in quality of life before and after DBS measured by EuroQol-5 domains
Timeframe: Pre-operative and at 3 months after stimulation
2
Change in freezing of gait before and after DBS, measured by freezing of gait questionnaire
Timeframe: Pre-operative and at 3 months after stimulation
3
Change in the number of sleep arousals per night
Timeframe: Pre-operative and at 3 months after stimulation
4
Change in Cardiovascular symptoms following DBS (continuous blood pressure)
Timeframe: Pre-operative and at 3 months after stimulation
5
Change in Cardiovascular symptoms pre-post DBS (change in postural blood pressure)
Timeframe: Pre-operative and at 3 months after stimulation
6
Change of power in alpha bands on polysomnography before and after DBS
Timeframe: Pre-operative and at 3 months after stimulation
7
Change of power in beta bands on polysomnography before and after DBS