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NCT Number: NCT04748640

Bilateral Essential Tremor Treatment With Gamma Knife

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tremor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Change in QUEST Score

    Time frame: 12 months

    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

  2. Patient-based Assessment of Utility

    Time frame: 12 months

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

Secondary outcomes

  1. Gait Assessment (NRS-11)

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    Patient-reported and blinded observer rating of the patient's ability to walk (Numerical rating scale (NRS-11) from 0 to 10, with 10 being best)

  2. Gait Assessment (missteps)

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    Number of missteps in a 6 m standardized tandem walk

  3. Falls

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    Number of falls in last month

  4. Speech Assessment (NRS-11)

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    Patient-reported and blinded observer rating of the patient's ability to speak (Numerical rating scale (NRS-11) from 0 to 10, with 10 being best)

  5. Numbness

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    Incidence of new-onset numbness

  6. Dysgeusia

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    Incidence of taste alterations

  7. Other adverse events

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    Incidence of other adverse events as classified in the CTCAE

  8. Tremor (CRST)

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    Assessment of tremor using the Clinical Rating Scale for Tremor (CRST) parts A (0-88) and B (0-36), higher scores correspond to a worse tremor).

  9. Quality of life (QUEST)

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    QUality of life in ESsential Tremor (QUEST) questionnaire (0-100 percent, higher scores correspond to a worse quality of life)

  10. Quality of life (CRST part C)

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    Part C of the Clinical Rating Scale for Tremor (CRST) (0-32, higher scores correspond to a worse quality of life)

  11. Health Utility (EQ-5D-5L)

    Time frame: Baseline, post operative month 3, 6, 12, 24, 36

    Health Utility measured using the EQ-5D-5L and computed using the Canadian preference weights. Values range from 0 to 1, with 1 representing a perfect health.

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Iorio-Morin

CONTACT

[email protected]

819-346-1110

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • University Health Network, Toronto

Registry information

Acronym: BEST-GK

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2021
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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