Device Stimulation for Episodic Migraine
Phase 2
- Conditions
- Health Condition 1: G438- Other migraine
- Registration Number
- CTRI/2023/10/058543
- Lead Sponsor
- Dept of Neurology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
diagnosed of having episodic migraine with more than 4 and less than 15 migrainous headache days per month and less than 15 headache days per month with persistent headaches despite of one month of stable migraine preventive treatment presenting to the OPD/ emergency in Neurology department of CMC Ludhiana.
Exclusion Criteria
1. Other neurological or neuropsychiatric diseases
2. Other chronic painful syndromes
3. Other types of primary or secondary headaches
4. Epilepsy
5. Metallic head implants or cardiac pacemaker
6. Pregnancy or lactation
7. Substance abuse
8. Brain surgery
9. Prior experience with tDCS
10. Known brain metastasis
11. Use of botulinum toxin in head and neck region during the 6 months prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in number of migrainous headache days over one monthTimepoint: one month
- Secondary Outcome Measures
Name Time Method 1. Change from baseline in number of headache days over one month <br/ ><br>2. Change in headache intensity from baseline <br/ ><br>a. By VAS score <br/ ><br>b. By HIT- 6 score <br/ ><br>3. Proportion of patients showing =50% reduction from baseline in headache days per month <br/ ><br>4. Change from baseline in days of use of acute migraine- specific medication per month <br/ ><br>5. Adverse effects of tDCS notedTimepoint: one month