Bilateral Essential Tremor Treatment With Gamma Knife
Recruiting
Phase 2
Phase 3
Interventional Study
Essential Tremor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Université de Sherbrooke · Other
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About This Trial
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 su…
Trial Locations
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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 …
Contacts