Clinical trial for Migraine
Official title The Effect of Remote Electrical Neuromodulation (REN) on Conditioned Pain Modulation (CPM) in Migraine and Fibromyalgia
ClinicalTrials.gov ID: NCT07841509
What this study is testing
- What it's testing
- Migraine and Fibromyalgia (FM) are chronic pain disorders characterized by altered central pain processing and impaired endogenous pain inhibition. FM presents with widespread musculoskeletal pain, fatigue, sleep disturbance, and cognitive symptoms and is strongly associated with central sensitization.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Adults diagnosed with migraine and/or fibromyalgia above 18 years old. For migraine:
- Has been diagnosed with migraine according to the ICHD-3 diagnostic criteria for migraine
- Experiencing 6-24 headache days per month
- Uses up to 1 prescribed preventive medication for migraine
- Did not make any changes to their migraine medications treatment in the month prior to the study enrollment. For Fibromyalgia:
You likely can't join if
- Has an implanted electrical and/or neurostimulation device (e.g., cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain...
- Patients with severe depression.
- Patients with known epilepsy. Use of any analgesics (OTC or prescribed) 24 hours prior to the study enrollment.
- Use of Cannabis within 10 days prior to the study enrollment.
- Use of opioids 2 months prior to the study enrollment.
- Pregnant or breastfeeding
See the full eligibility criteria
- \- Adults diagnosed with migraine and/or fibromyalgia above 18 years old. For migraine:
- Has been diagnosed with migraine according to the ICHD-3 diagnostic criteria for migraine
- Experiencing 6-24 headache days per month
- Uses up to 1 prescribed preventive medication for migraine
- Did not make any changes to their migraine medications treatment in the month prior to the study enrollment. For Fibromyalgia:
- Has been diagnosed with FM according to the ACR 2010/6 diagnostic criteria for FM with disease duration for at least 6 months prior to study enrolment.
- Did not make any changes to their FM medications in the month prior to the study enrollment.
- Naïve to the Nerivio device.
- Must be able and willing to comply with the protocol.
- Provides written informed consent form.
- Has an implanted electrical and/or neurostimulation device (e.g., cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant...
- Patients with severe depression.
- Patients with known epilepsy. Use of any analgesics (OTC or prescribed) 24 hours prior to the study enrollment.
- Use of Cannabis within 10 days prior to the study enrollment.
- Use of opioids 2 months prior to the study enrollment.
- Pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Bridgewater, New Jersey, United States
- Haifa, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bridgewater, New Jersey, United States; Haifa, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.