NCT04748640 Bilateral Essential Tremor Treatment With Gamma Knife
| NCT ID | NCT04748640 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Université de Sherbrooke |
| Condition | Essential Tremor |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-06-08 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2021-06-08 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Combined Phase II/III, multi-center, prospective, single-blinded trial. Ten (10) patients with essential tremor who previously underwent successful and uncomplicated GK thalamotomy for essential tremor will undergo a contralateral treatment. The incidence of side effects will be determined at 3 months postoperatively, graded per the CTCAE v5 and analyzed by a data safety monitoring board. Upon successful review, this Phase II trial will be converted to a Phase III trial of utility that will enrol 40 additional patients. The primary outcome will be the change in QUEST score at 12 months postoperatively, as well as a patient-reported assessment of Health Utility. Secondary outcomes will include objective tremor, gait and speech assessments (filmed and scored by blinded evaluators), as well as quality of life questionnaires and adverse events questionnaires. Outcomes will be assessed at baseline, as well as 3, 6, 12, 24 and 36 months post-operatively.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04748640 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Essential Tremor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04748640 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04748640 currently recruiting?
Yes, NCT04748640 is actively recruiting participants. Contact the research team at christian.iorio-morin@usherbrooke.ca for enrollment information.
Where is the NCT04748640 trial being conducted?
This trial is being conducted at Toronto, Canada, Sherbrooke, Canada.
Who is sponsoring the NCT04748640 clinical trial?
NCT04748640 is sponsored by Université de Sherbrooke. The trial plans to enroll 50 participants.