Clinical trial NCT05023460: Treatment of Chronic Cluster Headache with TENS and ONS
Official title: Treatment of Chronic Cluster Headache (Horton's Headache) with Transcutaneous Electrical Nerve Stimulation and Occipital Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Cluster Headache
Primary Headache Disorder
Headache
Cluster Headache
Pain
Cephalgia
Trigeminal Autonomic Cephalgia
Keywords: Occipital nerve stimulation
Neuromodulation
Transcutaneous electrical nerve stimulation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Danish Headache Center
First posted: 2021-08-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 30% reduction in CH attack frequency with TENS- and ONS-treatment
timeFrame: Primary evaluation through month 4 (TENS) and 7 (ONS, blinded)
measure: Incidence of treatment-emerged adverse events [safety] in TENS treatment
timeFrame: Evaluation at month 4
measure: Incidence of treatment-emerged adverse events [safety] in ONS treatment
timeFrame: Evaluation at month 7 (burst ONS) and 10 (tonic ONS)
Secondary outcomes:
measure: 30% reduction of pain intensity in CH attacks
timeFrame: Through month 4, 7 and 10
measure: Feasibility of TENS as a predictor for the efficacy of ONS treatment
timeFrame: Through month 4 and 10
measure: Non-inferiority study: Burst ONS versus tonic ONS
timeFrame: Through month 7 and 10
measure: Patient-perceived Global Impression of Change (PGIC)
timeFrame: At month 4, 7 and 10
measure: Reduction in background headache
timeFrame: At month 4, 7 and 10
measure: Hospital anxiety and depression scale (HADS)
timeFrame: At month 4, 7 and 10
measure: Health-related quality of life (EuroQoL 5D-5L)
timeFrame: At month 4, 7 and 10
measure: Self reported sleep quality
timeFrame: At month 4, 7 and 10
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: Ida S Fogh-Andersen, MD PhD fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Kaare Meier, MD PhD
role: STUDY_DIRECTOR
affiliation: University of Aarhus
name: Jens Christian H Sørensen, MD PhD DMSc
role: STUDY_CHAIR
affiliation: Danish Headache Centre
name: Rigmor H Jensen, MD PhD DMSc
role: STUDY_CHAIR
References: