NCT05157321

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

December 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

December 8, 2021

Last Update Submit

May 14, 2022

Conditions

Essential Tremor

Keywords

rTMS, essential tremors

Outcome Measures

Primary Outcomes (1)

  • change in severity of essential tremors

    Fahn, Tolosa, Marin Tremor Rating Scale

    1 day, 1 month, and 3 months following the end of treatment.

Study Arms (2)

Study Group

ACTIVE COMPARATOR

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

Device: Repetitive Transcranial Magnetic Stimulation

control group

SHAM COMPARATOR

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

Device: Sham Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

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.

Study Group
Sham Repetitive Transcranial Magnetic StimulationDEVICE

Sham Repetitive Transcranial Magnetic Stimulation

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Mohamed Al-Bahay M. Reda, professor

    Faculty of Medicine, Al-Azhar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 15, 2021

Study Start

December 10, 2021

Primary Completion

April 15, 2022

Study Completion

April 30, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)