Improving walking in Parkinson's patients with new brain stimulation techniques
ENGAGE-PD: Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease
This study is testing a new brain stimulation technique to see if it can help people with Parkinson's walk better and feel more stable.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05022147 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of alternating-frequency Deep Brain Stimulation (DBS) in enhancing gait and reducing postural instability in patients with Parkinson Disease. Participants will engage in gait tasks while their body movements and neural signals are recorded, allowing researchers to assess the impact of different stimulation frequencies. The study addresses a critical need, as current treatments for gait disorders in Parkinson's are often inadequate. By exploring this innovative approach, the research seeks to develop better therapies for managing these debilitating symptoms.
Who should consider this trial
Good fit: Ideal candidates include individuals with Parkinson Disease who have bilateral STN DBS and experience balance or walking impairments.
Not a fit: Patients who are severely dependent on walking aids or have significant comorbid conditions affecting gait may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and reduced fall risk for patients with Parkinson Disease.
How similar studies have performed: While there have been studies on DBS for Parkinson's, this specific approach using alternating frequencies is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bilateral STN DBS for PD * Medtronic Percept PC implanted DBS battery/pulse generator/recording system * Presence of balance and/or walking impairment and/or freezing of gait * Can walk without assistance, OFF meds, based on yes/no verbal response Exclusion Criteria: * Severity of gait impairment should not require dependency to walker or cane * Cannot tolerate monopolar stimulation at either of the two middle electrode contacts (prerequisite for the recording mode of the DBS) at high frequency (130 Hz) or low frequency (60 Hz). * Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases * Contraindication to physical therapy * Age \< 21 * Diagnosis of dementia * Not agreeable to having video taken of entire research visit
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: James Liao, MD PhD — The Cleveland Clinic
- Study coordinator: James Liao, MD PhD
- Email: liaoj2@ccf.org
- Phone: 216-445-1108
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.