Treatment of Chronic Cluster Headache with TENS and ONS
NCT ID: NCT05023460
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2021-08-27
2024-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Paresthesia-free (burst) ONS
Implanted 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.
Paresthesia-free (burst) ONS
Stimulation intensity target of 60% of paresthesia threshold.
Placebo
Implanted lead and IPG, deactivated.
Placebo
ONS system deactivated
Interventions
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Paresthesia-free (burst) ONS
Stimulation intensity target of 60% of paresthesia threshold.
Placebo
ONS system deactivated
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Danish Headache Center
OTHER
University of Aarhus
OTHER
Responsible Party
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Ida Stisen Fogh-Andersen
PhD fellow
Principal Investigators
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Ida S Fogh-Andersen, MD PhD fellow
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Kaare Meier, MD PhD
Role: STUDY_DIRECTOR
University of Aarhus
Jens Christian H Sørensen, MD PhD DMSc
Role: STUDY_CHAIR
University of Aarhus
Rigmor H Jensen, MD PhD DMSc
Role: STUDY_CHAIR
Danish Headache Centre
Locations
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Aarhus University Hospital
Aarhus N, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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HortONS
Identifier Type: -
Identifier Source: org_study_id