~2 spots leftby Mar 2026

Electrical Stimulation for Migraine

Recruiting in Palo Alto (17 mi)
Overseen byThomas Perreault, DPT
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Thomas W. Perreault, PT
No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this single-case experimental study is to investigate the effects of intramuscular electrical stimulation for the treatment of trigger points on reducing the frequency of headaches in a small sample of patients with chronic migraine. Additionally, this study seeks to investigate the effects of intramuscular electrical stimulation to trigger points on reducing the overall headache intensity, impact and disability using research validated questionnaires.Intramuscular electrical stimulation is a treatment that uses needles to deliver electrical current into muscles, or trigger points, for reducing pain and improving function. Trigger points are painful spots within taut bands of muscle that produce pain when pressure is applied or spontaneously. Participants will be included if they have at least a 6-month history of chronic migraine headache. Due to the nature of the single case experimental design study, participants will each serve as their own controls and be randomized to various baseline measures where they will record headaches and symptoms using an electronic headache diary. During the intervention phase, participants will receive dry needling treatment with intramuscular electrical stimulation, and will continue recording in the electronic headache diary and complete all self reported outcome measures at the final treatment session.

Eligibility Criteria

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.

Inclusion Criteria

At least a 6-month history of headaches consistent with a diagnosis of chronic migraine headache according to International Headache Society (IHS) criteria
Presence of trigger points in at least 2 of the following posterior cervical muscles, ipsilateral to the side of headache, and reproducing headache symptoms upon stimulation within the distribution of headache
splenius capitis
+3 more

Participant Groups

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.
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 Clinic Near You

Research Locations NearbySelect from list below to view details:
Wentworth Douglass HospitalDover, NH
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Who Is Running the Clinical Trial?

Thomas W. Perreault, PTLead Sponsor

References