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Completed

NCT Number: NCT04031781

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

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

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Key information

Conditions

Episodic Migraine Prophylaxis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold

Device

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

repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Migraine days

    Time frame: 2 months

    Number of days that the migraine attack lasts in

  2. Migraine attack severity

    Time frame: 2 months

    The intensity of pain that was assessed using the zero to ten Numeric Pain Rating Scale (NPRS)

  3. 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.

  4. Use of abortive pills

    Time frame: 2 months

    Number of pills used per month

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 24, 2019
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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