Last reviewed · How we verify
NCT07457268
Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine
NA trial testing Transcutaneous Auricular Trigeminal Nerve Stimulation in Migraine in 102 participants. Not yet recruiting.
1 April 2026
Quick facts
| Lead sponsor | Ordu University |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 102 |
| Start date | 1 March 2026 |
| Primary completion | 1 April 2026 |
| Estimated completion | 15 June 2026 |
Drugs / interventions tested
- Transcutaneous Auricular Trigeminal Nerve Stimulation
- Sham (No Treatment) — full drug profile →
Conditions studied
- Migraine — all drugs for Migraine →
Sponsor
Ordu University
Who can join
Adults 18 to 45, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized, sham-controlled, and double-blind clinical study aims to investigate the effects of transcutaneous auricular trigeminal nerve stimulation (taTNS) on intensity of headache, sleep quality, level of disability, and Heart rate variability (HRV) in patients with migraine. The inclusion criteria were: (1) being aged 18-45 years, (2) being literate in Turkish, (3) having been diagnosed with episodic migraine with aura and migraine without aura by a neurologist according to the International Classification of Headache Disorders, (4) having a history of migraine for at least 6 months with at least 2 attacks per month in the last 3 months. The exclusion criteria were: (1) being pregnant or breastfeeding; (2) regular use of analgesics or non-steroidal anti-inflammatory drugs for more than 15 days per month; (3) pacemaker implantation; (4) a history of addiction, syncope or abnormal ECG findings; (5) a history of intracranial haemorrhage or significant head trauma; (6) a diagnosis of epilepsy, severe anxiety or depression; (7) other types of headaches, including paresthesia or medication-overuse headaches; and (8) cognitive, visual, or auditory problems that would prevent participation in the study. The TaTNS was applied to the intervention and control (sham) groups by a physiotherapist (AP). The treatment session lasted 20 minutes and will apply three days a week for 12 weeks. The physical (age, gender, height, body weight), sociodemographic (marital status, education level), and clinical characteristics (chronic diseases, medications used, age of migraine onset, migraine frequency in the last month, migraine treatment history) of participants will be recorded. Primary outcome measurement: Migraine headache intensity (VAS), disability level (Migraine Disability Assessment Scale \[MIDAS\]), sleep quality (Pittsburgh Sleep Quality Index \[PSQI\]), Secondary outcome measurement: Heart rate variability (HRV) (Polar H7 device) will be assessed. All calculations will be performed using 5-minute Polar H7 recordings cleaned of artifacts, using Kubios HRV Premium software (Kubios Oy, Finland) in accordance with international standards.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07457268
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Transcutaneous Auricular Trigeminal Nerve Stimulation
Trials testing the same drug.
- NCT06730165 — Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation · NA · completed
Other recruiting trials for Migraine
Currently open trials in the same condition.
- NCT07419607 — MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducat · NA · recruiting
- NCT07487701 — Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study · NA · active not recruiting
- NCT07343427 — Impact of GON PRF on Central Sensitization in Migraine Patients · NA · active not recruiting
- NCT07336056 — Nerivio Efficacy Under High-Frequency Use · Phase 4 · active not recruiting
- NCT07385755 — Desvenlafaxine for Preventive Treatment of Frequent Migraines · NA · active not recruiting
Other Ordu University trials
Trials by the same sponsor.
- NCT07527676 — Hypoglycemia Fear Affect Autonomic Function, Physical Activity, and Exercise Capacity in Type I Diabetes · not yet recruiting
- NCT07504874 — The Effect of Gardening Activities on the Quality of Life of Students With Mild Intellectual Disability · NA · not yet recruiting
- NCT07500402 — THE EFFECT OF GARDENING ON PSYCHOLOGICAL WELL-BEING AND CARE AMONG NURSING HOME CARE STAFF · NA · not yet recruiting
- NCT07517549 — Sexual Health Education During Pregnancy · NA · recruiting
- NCT07046624 — Prevention of Phlebitis, Infiltration and Extravasation With Infusion Monitoring System · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07457268 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ordu University
- Last refreshed: 9 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07457268.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing