Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01294046 · ClinicalTrials.gov registry record · NA
Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT01294046: Completed NA study, sponsored by The Cleveland Clinic.
NCT01294046 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01294046, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
This investigation will gather information about a procedure called sphenopalatine ganglion (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who suffer migraine headaches which may result in chronic severe disability. The SPG is a small collection of nerve cells in the head, and is located near the base of the nose on either side. Participation involves the surgical implantation of an electrode (small electrical conductor) over the sphenopalatine ganglion. The electrode is connected to a stimulator which will enable treatment for migraine headaches. Tiny electrical current is delivered to the stimulator device by an internal pulse generator implanted in the area at the top of the chest, to stop the migraine headaches. The implant system will be controlled with a wireless remote provided after the implant procedure. Participation will record headache diaries throughout the study, which will last approximately 8½ months, and a yearly visit annually for five years.
Primary Outcome
Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.
Interventions
- DEVICE Deep Brain Stimulation of SPG for Migraine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-03 |
| Phase | NA |
What the finished NCT01294046 record still lists
NCT01294046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Deep Brain Stimulation of SPG for Migraine is the first listed.
NCT01294046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01294046 about?
NCT01294046 is a clinical study titled "Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches". This investigation will gather information about a procedure called sphenopalatine ganglion (SPG) stimulation, and its appropriateness, safety, and efficacy as a treatment for those who suffer migraine headaches which may result in chronic severe disability. The SPG is a small collection of nerve ce...
What is the current status of trial NCT01294046?
This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2011-03. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01294046?
The interventions under investigation include: Deep Brain Stimulation of SPG for Migraine (DEVICE).
Who is sponsoring clinical trial NCT01294046?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01294046's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia