Treatment for Essential Tremor using Gamma Knife
Bilateral Essential Tremor Treatment With Gamma Knife
This study is testing if a special treatment called Gamma Knife can help people with essential tremor who have already had a successful procedure on one side feel better and improve their quality of life.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT04748640 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Gamma Knife thalamotomy for patients with essential tremor who have previously undergone a successful procedure on one side. Initially, ten patients will receive treatment on the contralateral side, with a focus on assessing side effects and overall outcomes. If successful, the trial will expand to include an additional 40 patients, evaluating changes in tremor severity and quality of life over a 12-month period. Outcomes will be measured through various assessments, including patient-reported outcomes and objective evaluations by blinded assessors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a primary diagnosis of essential tremor who have previously undergone Gamma Knife thalamotomy and are experiencing tremors on the untreated side.
Not a fit: Patients with significant gait or speech impairments, or those unable to comply with follow-up schedules, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from essential tremor.
How similar studies have performed: Previous studies using Gamma Knife for essential tremor have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be ≥ 18 years * The patient has a primary diagnosis of ET or ET plus confirmed by a movement disorder neurologist; * The patient previously underwent a GK thalamotomy (\> 12 months ago); * The tremor on the untreated side negatively impacts the patients' quality of life; * The patient wants treatment of the contralateral side. Exclusion Criteria: * Clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2 falls/months, wheelchair, walker, cane use); * Clinically relevant speech impairment (e.g. impairment of intelligibility); * Inability to comply with the follow-up schedule; * Refusal of the treating physician.
Where this trial is running
Toronto, Ontario and 1 other locations
- Toronto Western Hospital, University Health Network — Toronto, Ontario, Canada (Recruiting)
- CIUSSS de l'Estrie-CHUS - Hôpital Fleurimont — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Christian Iorio-Morin
- Email: christian.iorio-morin@usherbrooke.ca
- Phone: 819-346-1110
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.