Is NCT05404581 recruiting in Charlottesville, VA?

Yes, NCT05404581 is currently recruiting participants at its Charlottesville, VA location. This neuropathic pain clinical trial is actively enrolling qualified participants.

How do I join the neuropathic pain clinical trial in Charlottesville?

To join this clinical trial in Charlottesville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Charlottesville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Neuropathic Pain Clinical Trial in Charlottesville, VA

Who Can Participate

Inclusion Criteria

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.

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. 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

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

Subjects with unstable ventricular arrhythmias

Subjects with atrial arrhythmias that are not rate-controlled

Severe hypertension (diastolic BP \> 100 on medication)

Subjects 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 the North American Neuromodulation Society; specifically:

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

Subjects participating or have participated in another clinical trial to investigate or treat chronic pain in the last 30 days

Subjects 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.

Subjects with brain tumors or any significant intracranial mass.

Subjects with a history of seizure

Any illness that in the investigator's opinion preclude participation in this study

Pregnancy or lactation

Subjects with a true allergy to opioid medications which would preclude PET imaging

Legal incapacity or limited legal capacity

Subjects with a deep brain stimulation implant

History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charlottesville?

Yes, this clinical trial (NCT05404581) has an active research site in Charlottesville, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Neuropathic Pain Treatment Options in Charlottesville, VA

If you're searching for neuropathic pain treatment options in Charlottesville, VA, this clinical trial (NCT05404581) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charlottesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced neuropathic pain specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all neuropathic pain clinical trials near you to find additional studies recruiting in your area.

Neuropathic Pain Clinical Trial in Charlottesville, VA

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About This Neuropathic Pain Study in Charlottesville