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Neurostimulation

Occipital Nerve Stimulation for Chronic Migraines

N/A

Recruiting

Research Sponsored by Alberta Health Services, Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failed standard medical management, meaning at least 3 conventional preventative therapies.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing a possible new treatment for people with chronic migraines.

Who is the study for?

This trial is for people with chronic trigeminal autonomic cephalalgias (TACs), including cluster headaches, who haven't found relief from at least three standard treatments. Participants must meet specific diagnostic criteria and agree to surgery. Those with untreated psychiatric conditions, medical reasons preventing surgery, or who don't speak English can't join.Check my eligibility

What is being tested?

The study is testing the effectiveness of an occipital nerve stimulator implant in treating TACs. This device is surgically placed under the skin near the occipital nerves at the base of the skull to help alleviate headache symptoms.See study design

What are the potential side effects?

Potential side effects may include pain or discomfort at the implant site, infection risk from surgery, possible nerve damage leading to muscle weakness or sensory changes, and device-related complications such as malfunction or battery issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have tried at least 3 standard treatments without success.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in headache frequency

Secondary outcome measures

Safety of Occipital Nerve Stimulation

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Industry standard stimulationActive Control1 Intervention

Standard sub threshold stimulation parameters

Group II: Experimental stimulationPlacebo Group1 Intervention

Sham stimulation

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alberta Health Services, CalgaryLead Sponsor

13 Previous Clinical Trials

2,581 Total Patients Enrolled

Media Library

Occipital nerve stimulator implant (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04937010 — N/A

Cluster Headache Research Study Groups: Industry standard stimulation, Experimental stimulation

Cluster Headache Clinical Trial 2023: Occipital nerve stimulator implant Highlights & Side Effects. Trial Name: NCT04937010 — N/A

Occipital nerve stimulator implant (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04937010 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots remaining in this experiment to which participants can still apply?

"Affirmative. The clinical trial register hosted on clinicaltrials.gov indicates that, as of February 14th 2022, this study is seeking participants. 20 applicants are expected to be accepted at a single medical centre since its inception on the 1st of February 2022."

Answered by AI

Do I qualify for enrollment in this clinical investigation?

"To qualify for this medical trial, individuals must suffer from trigeminal autonomic cephalgia and have an age between 18 and 100. The research team is seeking a total of 20 participants."

Answered by AI

Does the research encompass individuals above 45 years of age?

"As per the eligibility requirements for this trial, applicants must possess a minimum age of 18 and no more than 100 years."

Answered by AI

How many participants are contributing to this clinical research?

"Indeed, the clinicaltrials.gov portal displays that this trial has initiated recruitment procedures since its posting on February 1st 2022 and most recently updated on February 14th 2022. Currently, 20 participants are being sought from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

Fady Girgis 2022. "Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04937010.

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