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

NCT ID: NCT04031781

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2015-02-01

Brief Summary

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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

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Conditions

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Episodic Migraine Prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold

Intervention Type DEVICE

Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.

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

Group Type PLACEBO_COMPARATOR

repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold

Intervention Type DEVICE

Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.

Interventions

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repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold

Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Tamer Emara

Assistant professor of neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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FMASU 1171/2012

Identifier Type: -

Identifier Source: org_study_id

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