An interventional study of Paresthesia-free (burst) ONS and Placebo in Chronic Cluster Headache, Primary Headache Disorder and Headache, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's enrollment of 38 is close to the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Paresthesia-free (burst) ONS
Implanted lead and IPG, deactivated.
Device: Placebo
Stimulation intensity target of 60% of paresthesia threshold.
ONS system deactivated
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)
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.
Time frame: At month 4, 7 and 10
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.
Time frame: At month 4, 7 and 10
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.
Time frame: At month 4, 7 and 10
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.
Time frame: At month 4, 7 and 10
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.
Time frame: At month 4, 7 and 10
Plan to share: No
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Ran from Aug 2021 to primary completion in Jul 2024, 34 months.
Of 26 interventional studies with no phase under Cluster Headache, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's 34 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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