Insula Neuromodulation for Chronic Neuropathic Pain

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Neuropathic Pain, Chronic Pain

In brief

This study will comprehensively investigate the insula as a brain target for neuromodulation to treat chronic neuropathic pain.

Key facts

Study ID

NCT05404581

Run by

University of Virginia

People needed

12

Starts

2022-11-01

Expected to finish

2027-06-29

Last updated by the study team

2024-12-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women, between 18 and 80 years, inclusive
• Subjects who are able and willing to give consent and able to attend all study visits
• The pain is:
• 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.
• 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)
• Insula region must be apparent on MRI so that direct targeting can be performed for SEEG and DBS electrode placement.
• Able to communicate and report sensations during all stimulation testing
• Stable prescribed doses of all symptomatic pain medications for 30 days prior to study entry and for the duration of the study.
• Inclusion and exclusion criteria have been agreed upon by the principal investigator and the pain psychologist, both of whom have interviewed, examined and if appropriate provided psychotherapeutic intervention to the subject.

You may not qualify if…

• Idiopathic pain syndromes will be excluded. Examples include:
• Fibromyalgia syndrome
• temporomandibular joint disorders
• irritable bowel syndrome
• chronic headaches
• interstitial cystitis
• chronic pelvic pain
• whiplash-associated disorders
• Subjects deemed poor candidates by a multidisciplinary team of pain clinicians including specialists in neurosurgery, pain management, and pain psychology:
• Significant clinician concern(s) about reliability of subject-reported information, such as subject in active process of seeking disability for neuropathic pain
• Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-V as manifested by one (or more) of the following occurring within a 12 month period: Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household). Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
• Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
• Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
• Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score < 25
• Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:
• History of significant psychiatric disorder (e.g., comorbid schizophrenia, bipolar disorder, suicidal ideation/attempts) that could interfere with interpretation of study endpoints.
• Exhibiting current suicide ideation and/or a history of suicide attempt within past 2 years
• been hospitalized for the treatment of a psychiatric illness within the past 2 years
• received transcranial magnetic stimulation for depression treatment
• received electroconvulsive therapy for depression
• any presence or history of psychosis
• Subjects with unstable cardiac status including:
• Unstable angina pectoris on medication
• Subjects with documented myocardial infarction within six months of protocol entry
• Significant congestive heart failure defined with ejection fraction < 40

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.