Menu
Recruiting NCT04748640

Bilateral Essential Tremor Treatment With Gamma Knife

Phase II / Phase III Interventional Essential Tremor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gamma Knife VIM thalamotomy.
Who it may be relevant to
Registry conditions: Essential Tremor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure 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 measures

  • Change in QUEST Score [Time frame: 12 months]
  • Patient-based Assessment of Utility [Time frame: 12 months]
Secondary outcome measures (11)
  • Gait Assessment (NRS-11) [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]
  • Gait Assessment (missteps) [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]
  • Falls [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]
  • Speech Assessment (NRS-11) [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]
  • Numbness [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]
  • Dysgeusia [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]
  • Other adverse events [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]
  • Tremor (CRST) [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]
  • Quality of life (QUEST) [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]
  • Quality of life (CRST part C) [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]
  • Health Utility (EQ-5D-5L) [Time frame: Baseline, post operative month 3, 6, 12, 24, 36]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • Toronto Western Hospital, University Health Network — Toronto
  • CIUSSS de l'Estrie-CHUS - Hôpital Fleurimont — Sherbrooke

Identifiers

NCT: NCT04748640 · 20-5172

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗