The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis
1 other identifier
interventional
33
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 20, 2019
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedJuly 24, 2019
July 1, 2019
1.3 years
July 20, 2019
July 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Migraine days
2 months
Migraine attack severity
2 months
Functional disability
2 months
Use of abortive pills
2 months
Study Arms (2)
Receiving repetitive transcranial magnetic stimulation (rTMS)
ACTIVE COMPARATORThis 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 receiving placebo rTMS
PLACEBO COMPARATORThis group received Placebo rTMS was given with the same stimulation frequency at a fixed intensity of 50% of the machine output
Interventions
Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.
Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of neurology
Study Record Dates
First Submitted
July 20, 2019
First Posted
July 24, 2019
Study Start
May 1, 2013
Primary Completion
August 20, 2014
Study Completion
February 1, 2015
Last Updated
July 24, 2019
Record last verified: 2019-07