Repetitive Transcranial Magnetic Stimulation in Treatment and Prophylaxis of Chronic Migraine in Patients With no Prophylactic Treatment for the Last 3 Months (rTMS)

June 14, 2024 updated by: Tarik Mohamed Abdelnaeem, Sohag University

Repetitive Transcranial Magnetic Stimulation in Treatment of Chronic Migraine

Compared with the patients with episodic migraine those with chronic migraine have worst quality of life and more severe headache related disability we investigate Repetitive transcranial magnetic stimulation in treatment and prophylaxis of chronic migraine

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • A study sample of patients with chronic migraine according to international classification of headache disorders-3 (ICHD-3).
  • Patients are regular on follow up visits.

Exclusion criteria:

  • Patients with depression by Hamiliton scale of depression by using its Arabic version Translated by Dr Lotfy Fateem
  • patients on prophylactic medications for chronic migraine.
  • pregnancy.
  • cochlear implants, cardiac pacemaker, and metal body implanted in head-and-neck region.
  • Patients refused to give informed consent.
  • History of seizures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group (1) will rTMS over left motor cortex

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40
Device: transcranial magnetic stimulation device

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30
Active Comparator: group (2) will receive rTMS over left dorsolateral prefrontal cortex

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40
Device: transcranial magnetic stimulation device

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30
Active Comparator: group (3) will receive rTMS over left dorsolateral prefrontal cortex and left motor cortex

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40
Device: transcranial magnetic stimulation device

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30
Sham Comparator: group (4) will receive sham stimulation

Repetitive transcranial magnetic stimulation parameters:

stimulation site: the coil will be perpendicular over vertex of skull intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40
Device: transcranial magnetic stimulation device

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test
Time Frame: one month after treatment
improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test
one month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Tarek Mohamed, Sohag faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-05-06MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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