Insula Neuromodulation for Chronic Neuropathic Pain

This study is investigating a treatment called neuromodulation for chronic neuropathic pain. It involves placing electrodes in a part of the brain called the insula to deliver electrical stimulation. The goal is to see if this stimulation can help reduce pain. You might be able to join if you are between 18 and 80 years old and have chronic neuropathic pain that has lasted at least six months and is severe (an average pain score of 5 or more out of 10). The study will look at whether this treatment reduces your pain and if there are any side effects. Success for this study means finding an optimal region in the insula for pain relief and seeing positive analgesic effects from the stimulation.

Study design: This interventional study plans to enroll 12 participants. It is designed with a randomized, sham-stimulation-controlled, double-blinded, and cross-over approach for the outpatient stage.
What's involved: Participants will first have an inpatient stay for brain mapping and acute stimulation. If you respond well, you will then continue to an outpatient stage involving chronic deep brain stimulation.
Compensation: Not stated in the trial record.
Follow-up: Adverse events will be measured throughout the study, from enrollment up to 6 months after DBS (Deep Brain Stimulation) implantation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Insula Neuromodulation for Chronic Neuropathic Pain

Recruiting

NAAges 18–80InterventionalTreatment

University of Virginia

~12 participants

Updated 2024-12-10 on ClinicalTrials.gov

What's tested:neuromodulation

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Adverse events

Measured over Entire study period from enrollment through 6 months post DBS implantation

+1 more outcome measured

Conditions

Neuropathic Pain

Chronic Pain

Where it's being run

1 sites across 1 states

Virginia1

Study leadership

Jeff Elias, MD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Judy Beenhakker

[email protected]

434-982-1856

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

chronic with ≥6 month duration

severe is defined as: 'average' NPRS score of ≥ 5 out of 10 at current visit and the subject reports having a similar level of pain for at least the past two months

disabling and has resulted in an inability to work or perform ADLs in the home

medication-refractory to adequate trials of at least 3 prescription medications (including at least one current or past opioid) commonly used for symptomatic relief of pain. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect.

treatment-resistant and cannot be treated or has failed procedures including interventional therapies with injections, spinal neuromodulation with medication infusion or stimulation, and neurosurgical ablation surgery. 4. The pain is neuropathic or predominantly neuropathic if mixed components.

Subject suffering from a pure neuropathic pain syndrome will be included if the pain has resulted from a specific injury including trauma, ischemia, hemorrhage, infection, tumor or iatrogenic to either the peripheral (nerve, spinal root, plexus, cranial nerve) or to the central nervous system (spinal cord or brain) Etiologies include:

Poststroke pain

Thalamic pain

Spinal cord injury

Brachial plexus injury or limb avulsion

Peripheral nerve injury or painful neuropathy

Postherpetic neuralgia, Tolosa Hunt syndrome, or cavernous sinus syndromes

Trigeminal neuropathic pain (not trigeminal neuralgia) 5. Insula region must be apparent on MRI so that direct targeting can be performed for SEEG and DBS electrode placement. 6. Able to communicate and report sensations during all stimulation testing 7. Stable prescribed doses of all symptomatic pain medications for 30 days prior to study entry and for the duration of the study.

What this trial measures

Adverse eventsEntire study period from enrollment through 6 months post DBS implantation
Adverse event reporting will be collected throughout the study period. This will include neurological assessments by the study team postoperatively using the NIH Stroke Scale, MR imaging of implanted electrodes, comprehensive assessment of mood and cognition by a licensed psychologist, and vigilance for suicide with the asQ Screening Tool.
Pain intensityBaseline, 3 months post DBS stimulation, 3 months post sham stimulation
The primary efficacy outcome measure compares the change in pain intensity, as rated by the blinded subjects using the Numeric Pain Rating Scale (NPRS), between bilateral DBS of the insula and sham stimulation. The NPRS is an 11 point scale where 0 represents "no pain" and 10 represents the "worst possible pain." Clinical pain severity will be assessed daily in the home environment with a 7-day Ecological Momentary Assessment (NPRS rating) aggregated across days. The analysis will focus on DBS-ON Week 12 data relative to the DBS-OFF (Sham) Week 12 data, controlling for Baseline data.

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