Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

Alberta Health Services, Calgary

Status: Enrolling

Conditions: Trigeminal Autonomic Cephalgia

Treatments: Procedure: Occipital nerve stimulator implant

Study type: Interventional

Funder types: Other

Identifiers

NCT04937010

REB21-0839

Details and patient eligibility

About

The objective of this study is to determine the efficacy of occipital nerve stimulation (ONS) in the treatment of chronic trigeminal autonomic cephalalgias (TACs).

Full description

Several open studies and case series have shown improvement in pain scores using ONS specifically for cluster headache, which is the most common of the TACs. However, neuromodulation in the treatment of pain disorders is subject to strong placebo effect and bias, and the lack of controlled studies in this population makes its true efficacy unknown. Therefore, we plan to study ONS in a population of patients with chronic TACs using a double-blind, randomized, controlled, cross-over study. Using sub-threshold stimulation parameters, meaning patients will not know when therapeutic stimulation is active, subjects will rate their pain and quality of life during both therapeutic and sham stimulation periods. Following the cross-over period, all subjects will undergo therapeutic stimulation for 1-year in order to gauge long-term effects.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets ICHD-3 diagnostic criteria for the chronic form of one of the trigeminal autonomic cephalgias (outlined below), as determined by the treating neurologist.
• Failed standard medical management, meaning at least 3 conventional preventative therapies.

Exclusion criteria

• Presence of uncontrolled or untreated psychiatric disease
• Presence of medical contraindications to surgery
• Patient does not consent to surgery
• Non-English speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Industry standard stimulation

Active Comparator group

Description:

Standard sub threshold stimulation parameters

Treatment:

Procedure: Occipital nerve stimulator implant

Experimental stimulation

Sham Comparator group

Description:

Sham stimulation

Treatment:

Procedure: Occipital nerve stimulator implant