Bilateral Essential Tremor Treatment With Gamma Knife

NCT04748640 | Recruiting Phase 2 DMC

• 1 other identifier: 20-5172
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in QUEST Score

  Difference in QUEST score between baseline and the 12-month follow-up, with statistical significance defined as p = 0.05 and a minimum clinically important difference (MCID) defined as 5

  12 months

• Patient-based Assessment of Utility

  A patient-reported assessment of utility after 12 months using the question "Knowing what you know now, would you do this treatment again?".

  12 months

Secondary Outcomes (11)

• Gait Assessment (NRS-11)

  Baseline, post operative month 3, 6, 12, 24, 36

• Gait Assessment (missteps)

  Baseline, post operative month 3, 6, 12, 24, 36

• Falls

  Baseline, post operative month 3, 6, 12, 24, 36

• Speech Assessment (NRS-11)

  Baseline, post operative month 3, 6, 12, 24, 36

• Numbness

  Baseline, post operative month 3, 6, 12, 24, 36

Study Arms (1)

Treatment group

EXPERIMENTAL

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).

Procedure: Gamma Knife VIM thalamotomy

Interventions

Gamma Knife VIM thalamotomy PROCEDURE

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

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

CIUSSS de l'Estrie-CHUS - Hôpital Fleurimont

Sherbrooke, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Essential Tremor; Tremor; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Movement Disorders; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christian Iorio-Morin

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: All assessments filmed on video and scored by a blinded evaluator.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of neurosurgery

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: June 8, 2021
• Primary Completion: February 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)