Treatment of Chronic Cluster Headache with TENS and ONS
CompletedNot applicableNCT05023460
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The study is an investigator-initiated, prospective, randomized, placebo-controlled, double blind clinical trial that aims to investigate the effect of transcutaneous electrical nerve stimulation (TENS) and occipital nerve stimulation (ONS) on attack frequency and severity in patients with chronic cluster headache (CH). Study outline Month 1: Baseline. Establishment of a baseline profile of the participants CH attacks (severity, duration, medicine utilization etc), health-related quality of life (QoL) and symptoms of anxiety and depression. No active treatment. Follow-up visit after 30 days. Months 2-4: TENS period. All participants will receive TENS-treatment. Clinical follow-up visit by the end of month four. Months 5-7: Double-blinded, randomized experimental period. All participants will have an ONS-system (lead, impulse generator) implanted and will be randomized 1:1 to receive either 1) burst (paresthesia-free) ONS or 2) placebo (deactivated ONS system). Clinical follow-up visit by the end of month seven. Months 8-10: Open label period. All participants will receive tonic (conventional, paresthesia-inducing) ONS. Clinical follow-up visit by the end of month ten. During every study phase each participant will fill out a weekly electronic headache registration as well as answering questionnaires regarding health-related quality of life and symptoms of anxiety and depression before every follow-up visit.
Study details
- Official title
- Treatment of Chronic Cluster Headache (Horton's Headache) with Transcutaneous Electrical Nerve Stimulation and Occipital Nerve Stimulation
- Conditions
- Interventions
- Device: Paresthesia-free (burst) ONS
- Device: Placebo
- Sponsor
- University of Aarhus
- Collaborators
- Aarhus University Hospital; Danish Headache Center
- Start date
- 2021-08-27
- Primary completion
- 2024-07-15
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age 18 years and above 2. Signed informed written consent 3. Diagnosed with chronic CH according to the ICHD-3 criteria 4. 15 or more CH attacks per month 5. Stable use of preventive headache medication one month prior to enrollment Exclusion Criteria: 1. Other ongoing neuromodulation therapy 2. Current alcohol and/or drug abuse 3. Severe psychiatric disorder 4. Other chronic primary or chronic secondary headache disorder (e.g. chronic migraine) 5. Major posterior neck surgery in C2-C3 level and above 6. Pregnancy 7. Treatment with oral steroids or GON injection within one month of study participation
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05023460