Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients

Essential Tremor Clinical Trial

Official title:

Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05157321
• Other study ID #: 0000039
• Status: Completed
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• 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

Locations

Country	Name	City	State
Egypt	Al-Azhar university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in severity of essential tremors	Fahn, Tolosa, Marin Tremor Rating Scale	1 day, 1 month, and 3 months following the end of treatment.