Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients
Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Al-Azhar University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Study Group
The patients in this group will receive active repetitive transcranial magnetic stimulation sessions for 4 weeks.
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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.
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Sham Comparator: control group
The patients in this group will receive sham repetitive transcranial magnetic stimulation sessions for 4 weeks.
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Sham Repetitive Transcranial Magnetic Stimulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change in severity of essential tremors
Time Frame: 1 day, 1 month, and 3 months following the end of treatment.
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Fahn, Tolosa, Marin Tremor Rating Scale
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1 day, 1 month, and 3 months following the end of treatment.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mohamed Al-Bahay M. Reda, professor, Faculty of Medicine, Al-Azhar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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