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Investigation and Modulation of the Mu-Opioid Mechanisms in Migraine (in Vivo)

NCT02964741 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-08-26

Study results available
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Summary

This study investigates whether non-invasive brain stimulation, given for 20 minutes/once per day for ten days (M-F) can reduce migraine pain. Thirty patients will receive this treatment, while thirty will receive a "sham" procedure. Up to thirty healthy volunteers will be asked to undergo baseline assessments only (imaging, but no brain stimulation). Healthy volunteer data may be used from a prior study (NINDS-K23062946 project \[IRBMED #HUM00027383; Dr. Alexandre DaSilva, Principal Investigator\]).

Conditions

Interventions

DEVICE

Active Comparator

non-invasive brain stimulation (active protocol)

DEVICE

Sham Comparator

non-invasive brain stimulation (sham protocol)

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Alexandre F DaSilva, DDS, DMedSc · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-22
Primary Completion
2021-06-01
Completion
2021-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02964741 on ClinicalTrials.gov