The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis

July 23, 2019 updated by: Tamer Emara, Ain Shams University

The aim of the study was to examine the prophylactic role of repetitive transcranial magnetic stimulation (rTMS) on the frequency, and severity of migraine attacks in episodic migraineurs who failed medical treatment.

A group received 5 rTMS sessions, delivered over one week. Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration given at 5-Hz frequency and 100% motor threshold intensity and the placebo group received rTMS with the same stimulation frequency at a fixed intensity of 50% of the machine output

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

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

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cases diagnosed as episodic migraine with or without aura according to the ICHD 3rd edition
  • With a headache frequency of 4-14 per month for the last six months
  • Patients who had either an unsatisfactory response, declined or were intolerant to at least two prophylactic medications.

Exclusion Criteria:

  • Patients with past family history of seizures
  • Other chronic pain disorders
  • Severe depression (Beck Depression Inventory of 30 or more)
  • Other significant neurologic or psychiatric diagnosis including substance misuse
  • Metal implants in the head
  • Pregnant or breastfeeding ladies
  • Prior experience with TMS

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Receiving repetitive transcranial magnetic stimulation (rTMS)
This group received 5 rTMS sessions, delivered over one week over the left dorsolateral prefrontal cortex (LDLPFC ) at 5-Hz frequency and 100% motor threshold intensity.
Device: repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold
Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.
PLACEBO_COMPARATOR: Group receiving placebo rTMS
This group received Placebo rTMS was given with the same stimulation frequency at a fixed intensity of 50% of the machine output
Device: repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold
Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine attack frequency
Time Frame: 2 months
The primary outcome measure was defined as the reduction of number of migraine attacks by at least 50% after rTMS sessions.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine days
Time Frame: 2 months
Number of days that the migraine attack lasts in
2 months
Migraine attack severity
Time Frame: 2 months
The intensity of pain that was assessed using the zero to ten Numeric Pain Rating Scale (NPRS)
2 months
Functional disability
Time Frame: 2 months
Functional disability was measured using the HIT-6 score. Severe HIT-6 was defined as a score of 60 or more. A clinically significant change in the HIT-6 was defined as a change of five points or more.
2 months
Use of abortive pills
Time Frame: 2 months
Number of pills used per month
2 months

Collaborators and Investigators

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

Sponsor

Ain Shams University

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)

May 1, 2013

Primary Completion (ACTUAL)

August 20, 2014

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

July 20, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (ACTUAL)

July 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU 1171/2012

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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