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Chronic Cluster HeadacheHortONSNCT05023460

Treatment of Chronic Cluster Headache with TENS and ONS

A study testing Paresthesia-free (burst) ONS in people with Chronic Cluster Headache and Primary Headache Disorder, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Paresthesia-free (burst) ONS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteDenmark
Study dates
27 Aug 2021to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University Hospital

    Aarhus N, 8200

Other trials in Denmark

About this study

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

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

Read more

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.

Being tested
Paresthesia-free (burst) ONS, Placebo
Keywords
Occipital nerve stimulation, Neuromodulation, Transcutaneous electrical nerve stimulation
Medical subject headings
Cluster Headache, Headache Disorders, Primary, Headache, Pain, Trigeminal Autonomic Cephalalgias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paresthesia-free (burst) ONSDevice

    Stimulation intensity target of 60% of paresthesia threshold.

  • PlaceboDevice

    ONS system deactivated

Study groups in NCT05023460
Study groupRoleWhat they receive
Paresthesia-free (burst) ONSActive comparatorImplanted lead and impulse generator (IPG), paresthesia-free (burst) active stimulation. Lead implanted subcutaneously over greater occipital nerves. Implanted IPG capable of providing paresthesia-free stimulation continuously.
Receives: Device: Paresthesia-free (burst) ONS
PlaceboPlacebo comparatorImplanted lead and IPG, deactivated.
Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: Evaluation at month 4

  3. 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.

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

Secondary outcomes (8)

  1. 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.

    Measured: Through month 4, 7 and 10

  2. 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.

    Measured: Through month 4 and 10

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

    Comparing treatment outcome of burst ONS and tonic ONS.

    Measured: Through month 7 and 10

  4. 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.

    Measured: At month 4, 7 and 10

  5. Reduction in background headache

    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.

    Measured: At month 4, 7 and 10

  6. Hospital anxiety and depression scale (HADS)

    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.

    Measured: At month 4, 7 and 10

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

    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.

    Measured: At month 4, 7 and 10

  8. Self reported sleep quality

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

    Measured: At month 4, 7 and 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2021
  2. Study start27 Aug 2021
  3. Primary completion15 Jul 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05023460
Sponsor's protocol ID
HortONS
Acronym
HortONS
Status last verified
Dec 2024
First submitted
27 Jul 2021
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Fogh-Andersen IS, Sorensen JCH, Petersen AS, Jensen RH, Meier K. Safety and efficacy of occipital nerve stimulation as treatment of chronic cluster headache: an investigator-initiated, double-blind, randomized, placebo-controlled study. J Headache Pain. 2026 Mar 9;27(1):77. doi: 10.1186/s10194-026-02312-3.

    PubMed 41803706

  • Fogh-Andersen IS, Petersen AS, Jensen RH, Sorensen JCH, Meier K. Transcutaneous electrical nerve stimulation of the occipital nerves as treatment for chronic cluster headache. Headache. 2025 Jun;65(6):973-982. doi: 10.1111/head.14889. Epub 2024 Dec 20.

    PubMed 39703191

  • Fogh-Andersen IS, Sorensen JCH, Petersen AS, Jensen RH, Meier K. The HortONS study. Treatment of chronic cluster headache with transcutaneous electrical nerve stimulation and occipital nerve stimulation: study protocol for a prospective, investigator-initiated, double-blinded, randomized, placebo-controlled trial. BMC Neurol. 2023 Oct 21;23(1):379. doi: 10.1186/s12883-023-03435-9.

    PubMed 37865755

Questions about this trial

What is this clinical trial studying?

A study testing Paresthesia-free (burst) ONS in people with Chronic Cluster Headache and Primary Headache Disorder, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30% reduction in CH attack frequency with TENS- and ONS-treatment (time frame: Primary evaluation through month 4 (TENS) and 7 (ONS, blinded)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05023460, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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