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New treatment option for Neuropathic Pain
Official title Insula Neuromodulation for Chronic Neuropathic Pain
ClinicalTrials.gov ID: NCT05404581
What this study is testing
- What it's testing
- This study will comprehensively investigate the insula as a brain target for neuromodulation to treat chronic neuropathic pain.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Men and women, between 18 and 80 years, inclusive
- people 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...
You likely can't join if
- have been agreed upon by the principal investigator and the pain psychologist, both of whom have interviewed, examined and if appropriate provided...
- Idiopathic pain syndromes will be excluded. Examples include:
- Fibromyalgia syndrome
- temporomandibular joint disorders
- irritable bowel syndrome
- chronic headaches
See the full eligibility criteria
Who can join
- Men and women, between 18 and 80 years, inclusive
- people 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...
- treatment-resistant and cannot be treated or has failed procedures including treatment 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...
- 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
What rules you out
- 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. Exclusion Criteria:
- 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
- people 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
- people 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...
- 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...
- Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score \< 25
- people 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
- people with unstable cardiac status including:
- Unstable angina pectoris on medication
- people with documented myocardial infarction within six months of protocol entry
- Significant congestive heart failure defined with ejection fraction \< 40
- people with unstable ventricular arrhythmias
- people with atrial arrhythmias that are not rate-controlled
- Severe hypertension (diastolic BP \> 100 on medication)
- people with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- On medications that increases the bleeding risk, based on the published guidelines41 which are currently recognized by the American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine and...
- Aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abiciximab) for the last 7 days prior to treatment.
- Oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours.
- Intravenous or subcutaneous heparin-derived compounds for the last 48 hours.
- Individuals who are not able or willing to tolerate prolonged hospitalization with continuous video EEG monitoring
- people participating or have participated in another clinical trial to investigate or treat chronic pain in the last 30 days
- people with risk factors for intraoperative or postoperative bleeding from a documented coagulopathy or if their serum coagulation studies (platelet count, PT, PTT, and INR) exceed the institutional laboratory limits.
- people with brain tumors or any significant intracranial mass.
- people with a history of seizure
- Any illness that in the investigator's opinion preclude participation in this study
- Pregnancy or lactation
- people with a true allergy to opioid medications which would preclude PET imaging
- Legal incapacity or limited legal capacity
- people with a deep brain stimulation implant
- History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.