Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients
NCT ID: NCT05157321
Last Updated: 2022-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-12-10
2022-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Study Group
The patients in this group will receive active repetitive transcranial magnetic stimulation sessions for 4 weeks.
Repetitive Transcranial Magnetic Stimulation
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.
control group
The patients in this group will receive sham repetitive transcranial magnetic stimulation sessions for 4 weeks.
Sham Repetitive Transcranial Magnetic Stimulation
Sham Repetitive Transcranial Magnetic Stimulation
Interventions
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Repetitive Transcranial Magnetic Stimulation
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.
Sham Repetitive Transcranial Magnetic Stimulation
Sham Repetitive Transcranial Magnetic Stimulation
Eligibility Criteria
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Inclusion Criteria
2. Patient should have significant residual tremors despite of using appropriate medical treatment.
3. Age: patient should be above 18 years old.
4. Gender: males and females.
Exclusion Criteria
2. 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).
3. 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
18 Years
ALL
No
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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Ahmed Fathy Mohammed Mohammed
physician
Principal Investigators
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Mohamed Al-Bahay M. Reda, professor
Role: STUDY_CHAIR
Faculty of Medicine, Al-Azhar University
Locations
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Al-Azhar university
Cairo, , Egypt
Countries
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Other Identifiers
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0000039
Identifier Type: -
Identifier Source: org_study_id
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