Treatment of Chronic Cluster Headache (Horton's Headache) with Transcutaneous Electrical Nerve Stimulation and Occipital Nerve Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Incidence of treatment-emerged adverse events [safety] in TENS treatment
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years and above
- •Signed informed written consent
- •Diagnosed with chronic CH according to the ICHD-3 criteria
- •15 or more CH attacks per month
- •Stable use of preventive headache medication one month prior to enrollment
Exclusion Criteria
- •Other ongoing neuromodulation therapy
- •Current alcohol and/or drug abuse
- •Severe psychiatric disorder
- •Other chronic primary or chronic secondary headache disorder (e.g. chronic migraine)
- •Major posterior neck surgery in C2-C3 level and above
- •Treatment with oral steroids or GON injection within one month of study participation
Outcomes
Primary Outcomes
Incidence of treatment-emerged adverse events [safety] in TENS treatment
Time Frame: Evaluation at month 4
Treatment related adverse events and adverse device effects will be registered on an ongoing basis. Serious events will be handled immediately.
30% reduction in CH attack frequency with TENS- and ONS-treatment
Time Frame: Primary evaluation through month 4 (TENS) and 7 (ONS, blinded)
Proportion of participants with a positive treatment outcome of a 30% reduction in CH attack frequency compared to baseline. A CH attack is here defined as any attack recognised by the patient as a CH attack.
Incidence of treatment-emerged adverse events [safety] in ONS treatment
Time Frame: Evaluation at month 7 (burst ONS) and 10 (tonic ONS)
Treatment related adverse events and adverse device effects will be registered on an ongoing basis. Serious events will be handled immediately.
Secondary Outcomes
- Feasibility of TENS as a predictor for the efficacy of ONS treatment(Through month 4 and 10)
- Hospital anxiety and depression scale (HADS)(At month 4, 7 and 10)
- Health-related quality of life (EuroQoL 5D-5L)(At month 4, 7 and 10)
- Self reported sleep quality(At month 4, 7 and 10)
- Non-inferiority study: Burst ONS versus tonic ONS(Through month 7 and 10)
- Patient-perceived Global Impression of Change (PGIC)(At month 4, 7 and 10)
- Reduction in background headache(At month 4, 7 and 10)
- 30% reduction of pain intensity in CH attacks(Through month 4, 7 and 10)
Investigators
Ida Stisen Fogh-Andersen
PhD fellow
University of Aarhus