Treatment of Chronic Cluster Headache with TENS and ONS

University of Aarhus38 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Cluster Headache

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

30% reduction in CH attack frequency with TENS- and ONS-treatment

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.

Time frame: Primary evaluation through month 4 (TENS) and 7 (ONS, blinded)

Incidence of treatment-emerged adverse events [safety] in TENS treatment

Treatment related adverse events and adverse device effects will be registered on an ongoing basis. Serious events will be handled immediately.

Time frame: Evaluation at month 4

Incidence of treatment-emerged adverse events [safety] in ONS treatment

Treatment related adverse events and adverse device effects will be registered on an ongoing basis. Serious events will be handled immediately.

Time frame: Evaluation at month 7 (burst ONS) and 10 (tonic ONS)

Secondary Outcomes

30% reduction of pain intensity in CH attacks

Weekly self reported pain intensity on a numeric rating scale from 0-10 with 0 being "no pain" and 10 "the worst possible pain". Proportion of participants with a positive treatment outcome of a 30% reduction in pain intensity during CH attacks compared to baseline.

Time frame: Through month 4, 7 and 10

Feasibility of TENS as a predictor for the efficacy of ONS treatment

Comparison will be made of headache data from the last month of treatment with TENS and tonic ONS, respectively, to evaluate whether a 30% reduction in CH attack duration with TENS-treatment correlates to a 30% reduction in CH attack duration with ONS-treatment.

Time frame: Through month 4 and 10

Non-inferiority study: Burst ONS versus tonic ONS

Comparing treatment outcome of burst ONS and tonic ONS.

Time frame: Through month 7 and 10

Patient-perceived Global Impression of Change (PGIC)

The number of participants who rates their condition 'much improved' or 'very much improved' as assessed by PGIC.