Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2026-09-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Trigeminal Autonomic Cephalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Industry standard stimulation

Standard sub threshold stimulation parameters

Group Type ACTIVE_COMPARATOR

Occipital nerve stimulator implant

Intervention Type PROCEDURE

Implantation of occipital nerve stimulator and different stimulation parameters

Experimental stimulation

Sham stimulation

Group Type SHAM_COMPARATOR

Occipital nerve stimulator implant

Intervention Type PROCEDURE

Implantation of occipital nerve stimulator and different stimulation parameters

Interventions

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Occipital nerve stimulator implant

Implantation of occipital nerve stimulator and different stimulation parameters

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No