Back to resultsThe Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis
Primary Purpose
Episodic Migraine, Prophylaxis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold
repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold
Sponsored by
About this trial
This is an interventional prevention trial for Episodic Migraine focused on measuring 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
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Receiving repetitive transcranial magnetic stimulation (rTMS)
Group receiving placebo rTMS
Arm Description
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.
This group received Placebo rTMS was given with the same stimulation frequency at a fixed intensity of 50% of the machine output
Outcomes
Primary Outcome Measures
Migraine attack frequency
The primary outcome measure was defined as the reduction of number of migraine attacks by at least 50% after rTMS sessions.
Secondary Outcome Measures
Migraine days
Number of days that the migraine attack lasts in
Migraine attack severity
The intensity of pain that was assessed using the zero to ten Numeric Pain Rating Scale (NPRS)
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.
Use of abortive pills
Number of pills used per month
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04031781
Brief Title
The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis
Official Title
The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
August 20, 2014 (Actual)
Study Completion Date
February 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Migraine, Prophylaxis
Keywords
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Receiving repetitive transcranial magnetic stimulation (rTMS)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group receiving placebo rTMS
Arm Type
Placebo Comparator
Arm Description
This group received Placebo rTMS was given with the same stimulation frequency at a fixed intensity of 50% of the machine output
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold
Intervention Description
Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold
Intervention Description
Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.
Primary Outcome Measure Information:
Title
Migraine attack frequency
Description
The primary outcome measure was defined as the reduction of number of migraine attacks by at least 50% after rTMS sessions.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Migraine days
Description
Number of days that the migraine attack lasts in
Time Frame
2 months
Title
Migraine attack severity
Description
The intensity of pain that was assessed using the zero to ten Numeric Pain Rating Scale (NPRS)
Time Frame
2 months
Title
Functional disability
Description
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.
Time Frame
2 months
Title
Use of abortive pills
Description
Number of pills used per month
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis
We'll reach out to this number within 24 hrs