Chronic Migraine Clinical Trial
Official title:
Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
This study investigates whether unilateral and bilateral non-invasive brain stimulation, given for 20 minutes/once per day for twenty days (M-F) can reduce migraine pain. Fourty patients will receive treatment (20 unilateral treatment, and 20 bilateral treatment), while twenty will receive a "sham" procedure. Another 20 Episodic Migraine patients will be recruited for the observational aim of the study which does not include brain stimulation.
Clinical Trial: This is a phase 2, single center, three-arm, double-masked, randomized investigation and modulation of the µ-opioid and D2/D3 mechanisms in chronic migraine (in vivo). We will enroll 60 patients with Chronic Migraine divided into 3 Lab/Home-Based groups: 20 for the active unilateral M11-2 HD-tDCS group, 20 for the active bilateral M11-2 HD-tDCS group, and 20 for the sham M11-2 HD-tDCS group. Patients will complete a screening visit, baseline visit with MRI and PET session, 20 days of HD-tDCS brain stimulation treatments, as well as follow-up visits with an MRI and PET session. Observational Study Arm: 20 additional patients with low frequency EM (<8 attacks/month) patients (that did not undergo neuromodulation) will be recruited for the study. Historical data may be used in place of recruiting new participants. Data from these 20 EM volunteers will be compared to that of CM patients at baseline; however, they will not be part of the clinical trial. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05720819 -
Biofeedback-VR for Treatment of Chronic Migraine
|
N/A | |
| Not yet recruiting |
NCT06428838 -
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
|
Phase 3 | |
| Recruiting |
NCT05517200 -
Pilot Study for a Machine Learning Test for Migraine
|
||
| Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
| Completed |
NCT02514148 -
Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients
|
N/A | |
| Enrolling by invitation |
NCT02291380 -
A Study to Evaluate Botulinum Toxin Type A for Injection（HengLi®）for Prophylactic Treatment of Chronic Migraine
|
Phase 3 | |
| Completed |
NCT02122237 -
Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
|
Phase 3 | |
| Withdrawn |
NCT02122744 -
RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine
|
N/A | |
| Recruiting |
NCT02202486 -
Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI
|
N/A | |
| Completed |
NCT01709708 -
Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
|
Phase 4 | |
| Completed |
NCT01741246 -
Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging
|
N/A | |
| Completed |
NCT01090050 -
Treximet in the Treatment of Chronic Migraine
|
Phase 4 | |
| Recruiting |
NCT03507400 -
Introvision for Migraine and Headaches
|
N/A | |
| Completed |
NCT04161807 -
Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine
|
N/A | |
| Completed |
NCT03175263 -
OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain
|
N/A | |
| Withdrawn |
NCT04353505 -
Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache
|
Phase 1 | |
| Completed |
NCT01667250 -
Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
|
N/A | |
| Completed |
NCT01700387 -
A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency
|
Phase 4 | |
| Not yet recruiting |
NCT01135784 -
Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache
|
Phase 2 | |
| Completed |
NCT00772031 -
NINDS CRC Chronic Migraine Treatment Trial
|
Phase 3 |