Recruiting
Phase 2
Phase 3

Gamma Knife

Sponsor:

Université de Sherbrooke

Code:

NCT04748640

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gamma Knife VIM thalamotomy

Study Details

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.

Conditions

Essential Tremor

Study ID

NCT04748640

Start date

Jun 8, 2021

Status verified date

Nov, 2021

Completion date

Oct, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment group

Participants will undergo a thalamotomy contralateral to their previous treatment with Gamma Knife using a frame-based, Gamma Knife Perfexion or Icon unit (Elekta, Stockholm, Sweden).

Interventions

Gamma Knife VIM thalamotomy

Ablation of contralateral VIM nucleus of thalamus with GK using a frame-based, Gamma Knife Perfexion or Icon unit (Elekta, Stockholm, Sweden).

Primary outcome measure

  • Change in QUEST Score [ Time Frame: 12 months ]
  • Patient-based Assessment of Utility [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Christian Iorio-Morin

819-346-1110christian.iorio-morin@usherbrooke.ca

Locations

Toronto Western Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Martha Lenis, BHA

+14166035800martha.lenis@uhnresearch.ca

CIUSSS de l'Estrie-CHUS - Hôpital Fleurimont

Recruiting

Sherbrooke, Quebec, Canada

Contacts

Christian Iorio-Morin

819-346-1110christian.iorio-morin@usherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Nov 17, 2021

Last verified

Nov, 2021

Keywords

  • Gamma Knife Thalamotomy
  • Tremor
  • Essential Tremor
  • Dyskinesias
  • Neurologic Manifestations
  • Nervous System Diseases
  • Movement Disorders
  • Central Nervous System Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2021-11-17.