Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT02438553
• Date of registration: 03/05/2015
• Prospective Registration: No
• Primary sponsor: Neurolief Ltd.
• Public title: Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain
• Scientific title: A Prospective, Randomized, Single Blind, Parallel-group, Placebo Controlled Clinical Study to Evaluate the Short-term Effectiveness of Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation (OS-TNS) in Reducing Migraine Related Pain
• Date of first enrolment: May 2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02438553
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Rachel Hering, Dr.
• Affiliation: Director of headache clinic, Department of Neurology, Meir General Hospital, Kfar Saba, Israel.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with confirmed diagnosis of migraine headache without aura or with typical
migraine with aura (ICHD-II code 1.2.1 or 1.1).

- Subjects with 1-6 migraine episodes per month in the last 2 months.

- The subject is capable of understanding the study and to sign an informed consent.

Exclusion Criteria:

- Subjects who have concomitant epilepsy.

- History of neurosurgical interventions.

- Subjects with metal implants or shrapnel in their head, except for dental implants.

- Subjects with implanted cardiac pacemaker, neurostimulators, surgical clips (above
the shoulder line) or any medical pumps.

- History of drug abuse or alcoholism.

- History of medications overuse headache.

- Participation in current clinical study or participated in a clinical study within 3
months prior to this study.

- Skin lesion or inflammation at the region of the stimulating electrodes.

- Personality or somatoform disorder.

- Pregnancy or Lactation.

- Women of reproductive age not using efficient contraceptive method.

- History of cerebrovascular event.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Headache, Migraine

Intervention(s)

Device: OSTNS Neurostimulator

Device: Placebo OSTNS Neurostimulator

Primary Outcome(s)

Pain visual analogue scale (VAS) [Time Frame: 20-60 minutes of treatment.]

Secondary Outcome(s)

Sustained pain freedom at 24 hours [Time Frame: Baseline, 24 hours]

"Headache relief" rate- at 2 hours [Time Frame: Baseline, 2 hours]

"Responder" rate at 15 minutes of treatment [Time Frame: Baseline, 15 minutes of treatment]

Percentage of subjects who completed the treatment. [Time Frame: Baseline-20 minutes of treatment]

Functional disability change 2 hours from end of treatment [Time Frame: Baseline, 2 Hours post treatment]

Presence of nausea, vomiting, photophobia, phonophobia. [Time Frame: Baseline- 24 hours.]

"Responder" rate at 20-60 minutes of treatment. [Time Frame: 20-60 minutes of treatment.]

Pain free at 2 hours [Time Frame: Baseline, 2 hours]

Sustained "Responder" rate at 24 hours post treatment [Time Frame: Baseline, 24 hours post treatment]

Global impression of effect [Time Frame: Baseline- 24 hours.]

Sustained "headache relief" at 24 hours [Time Frame: Baseline, 24 hours]

Time until use of pain relief medication. [Time Frame: Baseline- 24 hours.]

Secondary ID(s)

NRLF-0086-14-MMC-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors