Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients

Not Applicable

Completed

• Conditions: Essential Tremor
• Interventions: Device: Sham Repetitive Transcranial Magnetic Stimulation; Device: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT05157321
• Lead Sponsor: Al-Azhar University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-12-08
• Study Start: 2021-12-10
• Study First Submitted QC: 2021-12-11
• Study First Posted: 2021-12-15
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-14
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Sham Repetitive Transcranial Magnetic Stimulation	The patients in this group will receive sham repetitive transcranial magnetic stimulation sessions for 4 weeks.
Study Group	Repetitive Transcranial Magnetic Stimulation	The patients in this group will receive active repetitive transcranial magnetic stimulation sessions for 4 weeks.

Primary Outcome Measures

Name	Time	Method
change in severity of essential tremors	1 day, 1 month, and 3 months following the end of treatment.	Fahn, Tolosa, Marin Tremor Rating Scale

Trial Locations

Locations (1)

Al-Azhar university; 🇪🇬 Cairo, Egypt