N/A
Completed N=68
Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
Source: ClinicalTrials.gov NCT01265797 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Mean Headache Days — 0.88; -0.52 headache days/ 28 day period — p=0.30
Summary
Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain relief in migraine patients. However, despite the number of CES studies done, many have been open label, single blinded, or have utilized a small group of patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Headache Days |
0.88; -0.52 | 0.30 |
| PRIMARY Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9) |
0; 0.30 | 0.98 |
| SECONDARY Headache Days |
0.67; 0.76 | 0.89 |
| SECONDARY Depression Score (Patient Health Questionnaire-9) |
1.58; 0.62 | 0.30 |
| SECONDARY Headache Impact Test-6 |
2.13; 1.22 | 0.75 |
| SECONDARY Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches) |
3.25; 2.65 | 0.73 |
| SECONDARY Generalized Anxiety Disorder Score (GAD 7) |
1.13; 1.27 | 0.98 |
| SECONDARY Somatic Symptom Severity (Patient Health Questionnaire 15) |
0.38; 0.33 | 0.97 |
| SECONDARY Somatic Symptom Score (Patient Health Questionnaire-15) |
0.84; 1.00 | 0.87 |
| SECONDARY Epworth Sleepiness Scale Score |
0.50; 0.35 | 0.92 |
Eligibility Criteria
Inclusion Criteria
- Subjects satisfying the IHS (International Headache Society) criteria for migraine
- Subjects have not achieved satisfactory pain control on their current medication
- Ability to maintain a daily headache diary
- Stable medication use related to migraine for at least 4 weeks prior to enrollment in the study
Exclusion Criteria
- Previous exposure to or experience with cranial electrotherapy stimulation (CES)
- Contraindications to Fisher Wallace stimulator, such as cardiac pacemakers or implantable defibrillators, known or suspected heart disease, or pregnancy
- Seizure disorders
Data sourced from ClinicalTrials.gov (NCT01265797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.