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Electrical Stimulation for Migraine

N/A
Recruiting
Led By Thomas Perreault, DPT
Research Sponsored by Thomas W. Perreault, PT
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

This trial will look at whether intramuscular electrical stimulation can reduce frequency and intensity of headaches in people with chronic migraine. Participants will be their own control and track their headaches before and after treatment.

Who is the study for?
This trial is for individuals who have been experiencing chronic migraines for at least six months. Participants should have trigger points in specific neck muscles that, when stimulated, reproduce their headache symptoms. It's not suitable for those who don't meet the International Headache Society criteria or lack these particular trigger points.
What is being tested?
The study tests if intramuscular electrical stimulation can reduce headache frequency and intensity in migraine sufferers. Patients will use dry needling combined with electrical currents on muscle trigger points and track their headaches using an electronic diary.
What are the potential side effects?
Potential side effects may include discomfort at needle insertion sites, muscle soreness after treatment, minor bleeding or bruising where needles are placed, and temporary increase in headache pain following the procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Headache Frequency
Secondary study objectives
Headache Impact Test-6 (HIT-6)
Migraine Disability Assessment Test (MIDAS)
Other study objectives
Numeric Pain Rating Scale
Pressure pain threshold

Trial Design

4Treatment groups
Experimental Treatment
Group I: 7 week baselineExperimental Treatment1 Intervention
Randomization to the fourth tier will include 7 weeks (49 days) of baseline measure, followed by 5 weeks of treatment and symptom monitoring
Group II: 6 week baselineExperimental Treatment1 Intervention
Randomization to the third tier will include 6 weeks (42 days) of baseline measures, followed by 5 weeks of treatment and symptom monitoring (phase B)
Group III: 5 week baselineExperimental Treatment1 Intervention
Randomization to the second tier will include 5 weeks (35 days) of baseline measures (phase A), followed by 5 weeks of treatment and symptom monitoring (phase B)
Group IV: 4 week baselineExperimental Treatment1 Intervention
Randomization to the first tier will include 4 weeks (28 days) of baseline measures (phase A), followed by 5 weeks of treatment and symptom monitoring (phase B)

Find a Location

Who is running the clinical trial?

Thomas W. Perreault, PTLead Sponsor
Thomas Perreault, DPTPrincipal InvestigatorMass General Brigham

Media Library

Dry Needling and intramuscular electrical stimulation to trigger points (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05893914 — N/A
Migraine Research Study Groups: 7 week baseline, 4 week baseline, 5 week baseline, 6 week baseline
Migraine Clinical Trial 2023: Dry Needling and intramuscular electrical stimulation to trigger points Highlights & Side Effects. Trial Name: NCT05893914 — N/A
Dry Needling and intramuscular electrical stimulation to trigger points (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05893914 — N/A
~0 spots leftby Nov 2024
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