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

Episodic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031781
• Other study ID #: FMASU 1171/2012
• Status: Completed
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: February 1, 2015

Study information

• Verified date: July 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 1, 2015
• Est. primary completion date: August 20, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders
• Prophylaxis

Intervention

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.
• repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold
Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine attack frequency	The primary outcome measure was defined as the reduction of number of migraine attacks by at least 50% after rTMS sessions.	2 months
Secondary	Migraine days	Number of days that the migraine attack lasts in	2 months
Secondary	Migraine attack severity	The intensity of pain that was assessed using the zero to ten Numeric Pain Rating Scale (NPRS)	2 months
Secondary	Functional disability	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
Secondary	Use of abortive pills	Number of pills used per month	2 months