Bilateral Essential Tremor Treatment With Gamma Knife

Last updated: November 8, 2021
Sponsor: Université de Sherbrooke
Overall Status: Active - Recruiting

Phase

2/3

Condition

Essential Tremor

Dystonia

Treatment

N/A

Clinical Study ID

NCT04748640
20-5172
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients must be ≥ 18 years
  • The patient has a primary diagnosis of ET or ET plus confirmed by a movement disorderneurologist;
  • 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

Exclusion Criteria:

  • Clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2falls/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.

Study Design

Total Participants: 50
Study Start date:
June 08, 2021
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Toronto Western Hospital, University Health Network

    Toronto, Ontario M5T 2S8
    Canada

    Active - Recruiting

  • CIUSSS de l'Estrie-CHUS - Hôpital Fleurimont

    Sherbrooke, Quebec
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.