Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients

Al-Azhar University

Status: Completed

Conditions: Essential Tremor

Treatments: Device: Sham Repetitive Transcranial Magnetic Stimulation; Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05157321

0000039

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient diagnosed with Essential tremors or Essential tremors plus based on the movement disorders consensus criteria(appendix 1)
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

1. Patients with history of seizures.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Study Group

Active Comparator group

Description:

The patients in this group will receive active repetitive transcranial magnetic stimulation sessions for 4 weeks.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

control group

Sham Comparator group

Description:

The patients in this group will receive sham repetitive transcranial magnetic stimulation sessions for 4 weeks.

Treatment:

Device: Sham Repetitive Transcranial Magnetic Stimulation