Treatment of Chronic Cluster Headache With TENS and ONS

Pain Clinical Trial

— HortONS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05023460
• Other study ID #: HortONS
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 31, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years and above

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:

1. Other ongoing neuromodulation therapy

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

Related Conditions & MeSH terms

• Cephalgia
• Chronic Cluster Headache
• Cluster Headache
• Headache
• Headache Disorders
• Headache Disorders, Primary
• Pain
• Primary Headache Disorder
• Trigeminal Autonomic Cephalgia

Intervention

Device:
• Paresthesia-free (burst) ONS
Stimulation intensity target of 60% of paresthesia threshold.
• Placebo
ONS system deactivated

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Primary evaluation through month 4 (TENS) and 7 (ONS, blinded)
Primary	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.	Evaluation at month 4
Primary	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.	Evaluation at month 7 (burst ONS) and 10 (tonic ONS)
Secondary	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.	Through month 4, 7 and 10
Secondary	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.	Through month 4 and 10
Secondary	Non-inferiority study: Burst ONS versus tonic ONS	Comparing treatment outcome of burst ONS and tonic ONS.	Through month 7 and 10
Secondary	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.	At month 4, 7 and 10
Secondary	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.	At month 4, 7 and 10
Secondary	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.	At month 4, 7 and 10
Secondary	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.	At month 4, 7 and 10
Secondary	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.	At month 4, 7 and 10