Adaptive deep brain stimulation for Parkinson's disease
Adaptive/Closed Loop vs. Continuous/Open Loop Deep Brain Stimulation of Subthalamic Nucleus: a Two-Phase, Cross-Over, Double-Blind Trial in Patients With Parkinson's Disease
This study is testing a new type of brain stimulation that adjusts to a person's needs to see if it can help people with Parkinson's disease feel better compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05402163 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of adaptive deep brain stimulation (aDBS) compared to continuous deep brain stimulation (cDBS) in patients with Parkinson's disease. By utilizing a novel implantable system that adjusts stimulation parameters based on the patient's clinical condition, the study aims to improve symptoms such as freezing of gait and speech issues. The study is designed as a two-phase, double-blinded, cross-over trial, allowing for a direct comparison of the two stimulation methods. Participants will be monitored for changes in their symptoms and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are patients with Parkinson's disease who are currently treated with bilateral subthalamic nucleus deep brain stimulation and experience disabling gait, balance, or speech issues.
Not a fit: Patients who have had previous deep brain stimulation surgery with non-Medtronic products or those with other disorders affecting outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the management of Parkinson's disease symptoms, leading to improved quality of life for patients.
How similar studies have performed: While adaptive deep brain stimulation is a novel approach, similar studies have shown promise in improving outcomes for patients with fluctuating symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PD treated with bilateral STN DBS using Medtronic lead * Able to provide informed consent and comply with study protocol * Need to replace the implantable pulse generator (IPG) due to battery end of life * Presence of disabling gait and/or balance and/or speech issues, as clinically judged by the PI and the patient * Evidence that these disabling gait and/or balance and/or speech issues are worsened by DBS, i.e. they improve after turning DBS off. * Use of contact 1 and/or 2 on one hemisphere and/or 9 and/or 10 on the other one * Good LFP signal (assessable only after IPG replacement with Percept) in at least one hemisphere Exclusion Criteria: * Previous DBS surgery without Medtronic products * Potential use of any therapeutic stimulation configuration (such as bipolar) during the study which will prevent the use of aDBS * Presence of any other disorders potentially impacting the outcome measures (e.g. orthopaedic issues) * Medically unstable * Severe non-motor problems, such as depression, dementia, etc.
Where this trial is running
Toronto, Ontario
- Movement Disorders Centre - Toronto Western Hospital — Toronto, Ontario, Canada (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.