Adaptive Deep Brain Stimulation for Multiple System Atrophy
MotIoN aDaptive Deep Brain Stimulation for MSA
NA · University of Oxford · NCT05197816
This study is testing whether a new type of brain stimulation can help improve walking and other symptoms in people with Multiple System Atrophy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of Oxford (other) |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT05197816 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of adaptive deep brain stimulation (aDBS) on patients with Multiple System Atrophy (MSA), a neurodegenerative condition characterized by gait and autonomic failure. The research focuses on a specific brain region, the Pedunculopontine Nucleus (PPN), to assess improvements in autonomic symptoms and gait. A total of 5 patients with disabling autonomic symptoms will be selected for this intervention, which aims to personalize stimulation based on physiological factors. The study also seeks to evaluate the safety of DBS in MSA and its impact on brain networks.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and over with a confirmed diagnosis of MSA and disabling autonomic symptoms.
Not a fit: Patients who are unfit for deep brain stimulation surgery or those with untreated mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with MSA by alleviating autonomic dysfunction and gait issues.
How similar studies have performed: While deep brain stimulation has been widely used for Parkinson's disease, the specific application of adaptive DBS for MSA is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Oxford, Oxfordshire
- John Radcliffe Hospital — Oxford, Oxfordshire, United Kingdom (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MSA - Multiple System Atrophy, deep brain stimulation, autonomic