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Completed

NCT Number: NCT05023460

Treatment of Chronic Cluster Headache with TENS and ONS

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.

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Key information

Conditions

Chronic Cluster Headache Brain Diseases Central Nervous System Diseases Cephalgia Cluster Headache Headache Headache Disorders Headache Disorders, Primary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Primary Headache Disorder Signs and Symptoms Trigeminal Autonomic Cephalalgias Trigeminal Autonomic Cephalgia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Pregnancy
  • Treatment with oral steroids or GON injection within one month of study participation

Treatment and study plan

Paresthesia-free (burst) ONS

Device

Stimulation intensity target of 60% of paresthesia threshold.

PLACEBO

Device

ONS system deactivated

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 30% reduction of pain intensity in CH attacks

    Time frame: Through month 4, 7 and 10

    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.

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

    Time frame: Through month 4 and 10

    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.

  3. Non-inferiority study: Burst ONS versus tonic ONS

    Time frame: Through month 7 and 10

    Comparing treatment outcome of burst ONS and tonic ONS.

  4. Patient-perceived Global Impression of Change (PGIC)

    Time frame: At month 4, 7 and 10

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

  5. Reduction in background headache

    Time frame: At month 4, 7 and 10

    Proportion of participants reporting a reduction in background headache. A positive treatment outcome will be defined as a two-point improvement on a four-point scale compared to baseline.

  6. Hospital anxiety and depression scale (HADS)

    Time frame: At month 4, 7 and 10

    HADS is a self-assessment questionnaire consisting of seven items each for depression and anxiety sub-scales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level.

    HADS score will be evaluated at every follow up and compared to baseline.

  7. Health-related quality of life (EuroQoL 5D-5L)

    Time frame: At month 4, 7 and 10

    The EQ 5D-5L is a well-established measure of health-related quality of life that is quantified as a utility (a measure of quality of life between 0 and 1) based on a danish value set. Furthermore a total score that ranges from 0-100 (visual analog scale), a higher score indicates better health-related quality of life.

  8. Self reported sleep quality

    Time frame: At month 4, 7 and 10

    Proportion af participants reporting a positive treatment outcome defined as a two-point improvement on a four-point scale compared to baseline.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Danish Headache Center

Registry information

Official study title

Treatment of Chronic Cluster Headache (Horton's Headache) with Transcutaneous Electrical Nerve Stimulation and Occipital Nerve Stimulation

Acronym: HortONS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2021
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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