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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Assessment (NRS-11) | 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) | Baseline, post operative month 3, 6, 12, 24, 36 |
| Gait Assessment (missteps) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Iorio-Morin | Contact | 819-346-1110 | christian.iorio-morin@usherbrooke.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital, University Health Network | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D014202 | Tremor |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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All assessments filmed on video and scored by a blinded evaluator.
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Number of missteps in a 6 m standardized tandem walk
| Baseline, post operative month 3, 6, 12, 24, 36 |
| Falls | Number of falls in last month | Baseline, post operative month 3, 6, 12, 24, 36 |
| Speech Assessment (NRS-11) | 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) | Baseline, post operative month 3, 6, 12, 24, 36 |
| Numbness | Incidence of new-onset numbness | Baseline, post operative month 3, 6, 12, 24, 36 |
| Dysgeusia | Incidence of taste alterations | Baseline, post operative month 3, 6, 12, 24, 36 |
| Other adverse events | Incidence of other adverse events as classified in the CTCAE | Baseline, post operative month 3, 6, 12, 24, 36 |
| Tremor (CRST) | 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). | Baseline, post operative month 3, 6, 12, 24, 36 |
| Quality of life (QUEST) | QUality of life in ESsential Tremor (QUEST) questionnaire (0-100 percent, higher scores correspond to a worse quality of life) | Baseline, post operative month 3, 6, 12, 24, 36 |
| Quality of life (CRST part C) | Part C of the Clinical Rating Scale for Tremor (CRST) (0-32, higher scores correspond to a worse quality of life) | Baseline, post operative month 3, 6, 12, 24, 36 |
| Health Utility (EQ-5D-5L) | 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. | Baseline, post operative month 3, 6, 12, 24, 36 |
| CIUSSS de l'Estrie-CHUS - Hôpital Fleurimont | Recruiting | Sherbrooke | Quebec | Canada |
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