Clinical trial NCT05157321: Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients
Official title: Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Keywords: rTMS, essential tremors
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in severity of essential tremors
timeFrame: 1 day, 1 month, and 3 months following the end of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar university
Study officials:
affiliation: Faculty of Medicine, Al-Azhar University
name: Mohamed Al-Bahay M. Reda, professor
role: STUDY_CHAIR
References: