Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor
VIMBIL
Other study identifiers
Sponsor study identifier
Secondary identifiers
OTHER · IDRCB
OTHER · APHM
interventional
33
1 country
1
Study Start
June 3, 2014
Actual (reported)Primary Completion
April 16, 2021
Actual (reported)Study Completion
April 4, 2023
Actual (reported)Brief Summary
Essential tremor (ET) is the most frequent movement disorder. Its prevalence is about 1/200 implying that at least 300 000 peoples are concerned in France. Its frequency increase with age (14% of patients 65 yo). The diagnostic criteria are postural and kinetic tremor that can be associated with head/voice tremor. ET induces a social impairment but also difficulties to perform any task requiring dexterity. With time, tremor can be so severe that every activity of daily living is impaired with loss of autonomy. Treatment such as betablockers, primidone or antiepileptics might have some efficacy at the beginning. But as the severity of the tremor increases, there is lack of efficacy. Deep Brain stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus can be proposed. However, in case of medical or surgical contra-indication, Gamma Knife (GK) radiosurgery thalamotomy can be an alternative option. Patients will be included with a minimum of 12 months after having the first thalamotomy (Gamma Knife 1) (done on the most annoying side) subject to no significant deterioration in cognitive assessment, voice assessment and balance and postural assessment or neuroradiological abnormality. Patients will be assessed with Magnetic resonance imaging (MRI) cerebral, clinical assessment (tremor rating scale) impairment of activity of daily living, neuropsychological evaluation, voice assessment and balance and postural assessment. The second thalamotomy (Gamma Knife 2) will be proposed and a monitoring at M6 and M12 will be done. This study will demonstrate the feasibility and tolerance of bilateral GK radiosurgery thalamotomy in ET patients with severe impairment.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 33 participants
- Study completion date
April 4, 2023
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
June 3, 2014
Actual (reported)First Submitted
July 6, 2016
Actual (reported)First Posted
July 11, 2016
Actual (reported)Primary Completion
April 16, 2021
Actual (reported)Study Completion
April 4, 2023
Actual (reported)
- Last Updated
- April 14, 2023
- Status Verified
- March 2023
- Last Update Submitted
- April 12, 2023