NCT05023460: HortONS

Treatment of Chronic Cluster Headache with TENS and ONS

Completed NA Last updated 5 December 2024

What this trial tests

NA trial testing Paresthesia-free (burst) ONS in Chronic Cluster Headache in 38 participants. Completed in 31 July 2024.

Timeline

27 August 2021

Primary endpoint
15 July 2024

31 July 2024

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	38
Start date	27 August 2021
Primary completion	15 July 2024
Estimated completion	31 July 2024
Sites	1 location across Denmark

Drugs / interventions tested

• Paresthesia-free (burst) ONS
• Placebo

Conditions studied

• Chronic Cluster Headache — all drugs for Chronic Cluster Headache →
• Primary Headache Disorder — all drugs for Primary Headache Disorder →
• Headache — all drugs for Headache →
• Cluster Headache — all drugs for Cluster Headache →

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Chronic Cluster Headache or Primary Headache Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Challenges and complexities in designing cluster headache prevention clinical trials: A narrative review.
   Dodick DW, Goadsby PJ, Ashina M, Tassorelli C, et al · · 2022 · cited 17× · PMID 35363381 · DOI 10.1111/head.14292
2. 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.
   Fogh-Andersen IS, Sørensen JCH, Petersen AS, Jensen RH, et al · · 2023 · cited 5× · PMID 37865755 · DOI 10.1186/s12883-023-03435-9
3. Transcutaneous electrical nerve stimulation of the occipital nerves as treatment for chronic cluster headache.
   Fogh-Andersen IS, Petersen AS, Jensen RH, Sørensen JCH, et al · · 2025 · cited 2× · PMID 39703191 · DOI 10.1111/head.14889
4. Safety and efficacy of occipital nerve stimulation as treatment of chronic cluster headache: an investigator-initiated, double-blind, randomized, placebo-controlled study.
   Fogh-Andersen IS, Sørensen JCH, Petersen AS, Jensen RH, et al · · 2026 · PMID 41803706 · DOI 10.1186/s10194-026-02312-3