Back to resultsRepetitive Transcranial Magnetic Stimulation in Essential Tremors Patients
Primary Purpose
Essential Tremor
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sham Repetitive Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring rTMS, essential tremors
Eligibility Criteria
Inclusion Criteria:
- Patient diagnosed with Essential tremors or Essential tremors plus based on the movement disorders consensus criteria(appendix 1)
- Patient should have significant residual tremors despite of using appropriate medical treatment.
- Age: patient should be above 18 years old.
- Gender: males and females.
Exclusion Criteria:
- Patients with history of seizures.
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).
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
Sites / Locations
- Al-Azhar university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Study Group
control group
Arm Description
The patients in this group will receive active repetitive transcranial magnetic stimulation sessions for 4 weeks.
The patients in this group will receive sham repetitive transcranial magnetic stimulation sessions for 4 weeks.
Outcomes
Primary Outcome Measures
change in severity of essential tremors
Fahn, Tolosa, Marin Tremor Rating Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05157321
Brief Title
Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients
Official Title
Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
rTMS, essential tremors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
The patients in this group will receive active repetitive transcranial magnetic stimulation sessions for 4 weeks.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
The patients in this group will receive sham repetitive transcranial magnetic stimulation sessions for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Repetitive Transcranial Magnetic Stimulation
Intervention Description
Sham Repetitive Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
change in severity of essential tremors
Description
Fahn, Tolosa, Marin Tremor Rating Scale
Time Frame
1 day, 1 month, and 3 months following the end of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient diagnosed with Essential tremors or Essential tremors plus based on the movement disorders consensus criteria(appendix 1)
Patient should have significant residual tremors despite of using appropriate medical treatment.
Age: patient should be above 18 years old.
Gender: males and females.
Exclusion Criteria:
Patients with history of seizures.
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).
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Al-Bahay M. Reda, professor
Organizational Affiliation
Faculty of Medicine, Al-Azhar University
Official's Role
Study Chair
Facility Information:
Facility Name
Al-Azhar university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation in Essential Tremors Patients
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