Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients

Study Overview
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Brief Summary
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The aim of the study is to investigate the Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors.

Detailed Description
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Prior to start of rTMS sessions, Clinical evaluation and scaling of tremors using the ET rating scale (Fahn, Tolosa, Marin Tremor Rating Scale) will be employed on the participants in both groups. rTMS frequency of 1Hz will be delivered to each of the participants in both groups. Each session will be administered once daily for 3 days a week for 4 weeks. 1200 pulses (30 pulses per train with total 40 trains having inter-train delay of 3 seconds) per session will be provided with the coil placed on both cerebellar hemispheres. rTMS frequency of 1Hz was kept constant based on previous studies. rTMS sessions will be administered by trained professionals who was kept blinded to the research protocols used in the study. After completion of therapeutic programs (after 4 weeks), the participants will be asked to undergo post assessment of Fahn, Tolosa, Marin Tremor Rating Scale at the end of last rTMS session, 1 month, 3 months later.

Official Title
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Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors

Conditions
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Essential Tremor

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation
* Device: Sham Repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient diagnosed with Essential tremors or Essential tremors plus based on the movement disorders consensus criteria(appendix 1) Patient should have significant residual tremors despite of using appropriate medical treatment. Age: patient should be above 18 years old. Gender: males and females. Exclusion Criteria: Patients with history of seizures. Patient receiving tremor active drugs including: Central cholinergic drugs (acetylcholine chloride, muscarinic and nicotinic agonists, anticholinesterases, and aminopropranolols) Central monoaminergic drugs (neuroleptics, phenylethylamines, and indoles) Peripheral adrenergic drugs (lithium carbonate, amphetamine sulfate, adrenocorticosteroids, and thyroid hormone supplements) Anticonvulsants (valproic acid), bronchodilators (theophylline and terbutaline sulfate) Antidepressants (amitriptyline hydrochloride). patients who have metal or electronic device implanted in their body such as : cardiac peace maker Aneurysm clips or coils Stents in the neck or brain Deep brain stimulators Spinal cord stimulators Electrodes to monitor brain activity Metallic implants in ears and eyes Bullet fragments in or near the head Baclofen pumps Other metal devices or object implanted in or near the head

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group<br>The patients in this group will receive active repetitive transcranial magnetic stimulation sessions for 4 weeks. | Device: Repetitive Transcranial Magnetic Stimulation<br>* TMS device will deliver repetitive trains of magnetic pulses using Magstim Rapid 2 with angulated figure of eight shaped coil. The device comprised two-channel Neuro-EMG-MS digital system for determining the motor threshold of the patients that will be used for establishing the threshold intensity for stimulation. The figure of eight-shaped coil generated a magnetic field of up to 4 Tesla that penetrates the cranium, enters into the soft tissue of the brain and henceforth stimulates the motor neurons.<br>|
| Sham Comparator: control group<br>The patients in this group will receive sham repetitive transcranial magnetic stimulation sessions for 4 weeks. | Device: Sham Repetitive Transcranial Magnetic Stimulation<br>* Sham Repetitive Transcranial Magnetic Stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in severity of essential tremors | Fahn, Tolosa, Marin Tremor Rating Scale | 1 day, 1 month, and 3 months following the end of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS, essential tremors