Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031781
Recruitment Status : Completed
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Tamer Emara, 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


Condition or disease Intervention/treatment Phase
Episodic Migraine Prophylaxis Device: repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold Device: repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold Not Applicable

Layout table for study information
Study Type : Interventional
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : August 20, 2014
Actual Study Completion Date : February 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Layout table for additonal information
Responsible Party: Tamer Emara, Assistant professor of neurology, Ain Shams University
ClinicalTrials.gov Identifier: NCT04031781    
Other Study ID Numbers: FMASU 1171/2012
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tamer Emara, Ain Shams University:
rTMS = repetitive transcranial magnetic stimulation
LDLPFC = Left dorsolateral prefrontal cortex
HIT 6 = Headache Impact test
NPRS = Numeric Pain Rating Scale
ICHD = The international classfication of Headache disorder
MT= Motor threshold
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases