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

Not Applicable

Completed

• Conditions: Prophylaxis; Episodic Migraine
• Interventions: Device: repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold; Device: repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold

• Registration Number: NCT04031781
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2014-08-20
• Study Completion: 2015-02-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-20
• Study First Submitted QC: 2019-07-23
• Last Update Submitted: 2019-07-23
• Study First Posted: 2019-07-24
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group receiving placebo rTMS	repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold	This group received Placebo rTMS was given with the same stimulation frequency at a fixed intensity of 50% of the machine output
Receiving repetitive transcranial magnetic stimulation (rTMS)	repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Functional disability	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.
Use of abortive pills	2 months	Number of pills used per month
Migraine days	2 months	Number of days that the migraine attack lasts in
Migraine attack severity	2 months	The intensity of pain that was assessed using the zero to ten Numeric Pain Rating Scale (NPRS)