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Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor

2016-07-12 00:53:21 | BioPortfolio

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 difficultiesto 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 Betabloquers, 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 VIM (small nucleus within 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 IRM 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Patients With Severe Essential Tremor

Intervention

Gamma Knife® radiosurgery bilateral

Location

Assistance Publique Hôpitaux de Marseille
Marseille
France
13354

Status

Recruiting

Source

Assistance Publique Hopitaux De Marseille

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-12T00:53:21-0400

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