Chronic Pain Clinical Trial
Official title:
Technology Development for Closed-loop Deep Brain Stimulation to Treat Refractory Neuropathic Pain
Verified date | November 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but current technology is unable to reliably achieve long-term pain symptom relief. A "one-size-fits-all" approach of continuous, 24/7 brain stimulation has helped patients with some movement disorders, but the key to reducing pain may be the activation of stimulation only when needed, as this may help keep the brain from adapting to stimulation effects. By expanding the technological capabilities of an investigative brain stimulation device, the investigators will enable the delivery of stimulation only when pain signals in the brain are high, and then test whether this more personalized stimulation leads to reliable symptom relief for chronic pain patients over extended periods of time.
Status | Active, not recruiting |
Enrollment | 4 |
Est. completion date | June 2026 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Age = 21 years - Clinical diagnosis of post-stroke pain (thalamic pain), spinal cord injury or phantom limb pain with allodynia or dysesthesia with pinprick anesthesia or hypoesthesia on the affected hemibody or limb (anesthesia dolorosa). - For Post-Stroke Pain: Stroke of ischemic etiology only. MRI done within one year of the first visit showing a lesion that involves the contralateral brainstem, thalamus or cortex. The lesion will involve cortical-subcortical areas in topography consistent with sensory thalamocortical connections. This will include patients with infarcts in the territory of the middle cerebral artery or those with cavernous malformations. A more recent MRI may be required if the patient's condition changed within the previous year. - For Phantom limb pain: MRI done within one year not showing any contraindication to surgery such as mass, lesion, hemorrhage or other abnormality near target - For Spinal Cord Injury pain: MRI done within one year not showing contraindication to surgery such as mass, lesion, hemorrhage or other abnormality near target - One year or more of medically refractory severe pain (see below) - Average daily pain for the past 30 days reported as >5 on a 0-10 numeric rating scale (NRS) - Failure to respond adequately to at least one antidepressant, one anti-seizure medication and one oral narcotic with current stable doses of medications. - Ability to speak / read English - Capable of understanding and providing informed consent - Stable doses of pain medications (e.g. anticonvulsant drug, anti-depressants, and opioids etc.) - Women of childbearing age must be on regular use of an accepted contraceptive method(s). Exclusion Criteria: - Study subjects will be adults with refractory chronic neuropathic pain. - Pregnancy or breast feeding - Inability to speak and / or read English - Inability to give informed consent - Significant cognitive impairment or Dementia (MoCA < 25) - Aphasia severe enough to limit the consent process or communication between the investigators and the patient. Patients with mild or recovering aphasia may be considered candidates at the discretion of the PI. - Active depression (BDI > 20) or other untreated or uncontrolled psychiatric illness (active general anxiety disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), or personality disorders (e.g. multiple personality disorder, borderline personality disorder, etc.) or other neuropsychiatric conditions that evaluating psychiatrist would recommend exclusion of patient after neuropsychiatric evaluation. - Suicide attempt </= 12 months or imminent suicide risk - History of substance abuse in past 3 years. - Major medical co-morbidities increasing the risk of surgery including uncontrolled hypertension, severe diabetes, major organ system failure, history of hemorrhagic stroke, need for chronic anticoagulation other than aspirin, active infection, immunocompromised state or malignancy with < 5 years life expectancy - Inability to stop Coumadin or platelet anti-aggregation therapy for surgery and after surgery. Patients taking these medications will need to discuss the need/risk of continuing these medications with their physicians and the PI or study personnel may contact the treating physician(s) as well to discuss the risks of anticoagulation / antiaggregation therapy discontinuation. - Coagulopathy. Patients will be excluded unless assessed and cleared by hematology. - MRI (done within one year of the first visit) with significant abnormalities other than those associated with the neurological disorder causing chronic pain. - Implantable hardware not compatible with MRI or with the study. - Inability to comply with study follow-up visits - Previous ablative intracranial surgery for the management of the thalamic pain syndrome. - Previously implanted with deep brain stimulation system or any previously implanted device treatment involving brain stimulation - Major neurological disorder other than the one that led to the chronic pain including epilepsy, neurodegenerative condition or any history of seizure - Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition - Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump - Allergies or known hypersensitivity to materials in the Activa PC+S system (i.e. titanium, polyurethane, silicone, polyetherimide, stainless steel). - Pregnancy or lack of regular use of contraceptives. Patients who become pregnant after enrollment may be excluded from the study. Patients who become pregnant prior to the surgical implantation of the DBS systems will be excluded from the study. - Patients may be excluded from enrollment due to a condition that, in the judgment of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS. |
Country | Name | City | State |
---|---|---|---|
United States | University of California | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Prasad Shirvalkar, MD, PhD | National Institute of Neurological Disorders and Stroke (NINDS), United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Becks Depression Inventory | The Becks Depression Inventory is commonly used assessment tools to quantify and track depression mood state over time. Its a single value outcome measurement ranging from 0 to 63, with 63 being the most depressed. | 2 years | |
Other | Becks Anxiety Inventory | The Becks Anxiety Inventory is commonly used assessment tools to quantify and track anxious mood state over time.Its a single value outcome measurement ranging from 0 to 63, with 63 the most anxious. | 2 years | |
Other | NIH PROMIS Toolbox (Patient Impression) | The NIH PROMIS toolbox contains a host of survey questions tailored to measurement of specific disease states such as pain, global health and function.
The patient impression evaluates patient self-evaluation and physician evaluation of the patient's general health ranging form 0 to 7 with 7 being the worst general health. |
2 years | |
Other | Pain Medication Usage | We will calculate total number of of breakthrough pain medication pills (eg. opioids, NSAIDs and neuropathic pain medication) used each month, to evaluate if analgesia from DBS reduces average usage. | 2 years | |
Other | Activity Tracker (Fitbit) - Heartrate | Each patient will be given a fitbit activity monitor which can record steps taken, flights of stairs climbed, heart rate and sleep quality. These measures will be used to infer functional improvement over time. Heartrate will be tracked as beats per minute (bpm) and the association of bpm with changes in NRS pain will be used to correlate changes in heartrate with pain levels. | 2 years | |
Primary | Visual Analog Score | Visual Analog Score is indicated by the patient by marking a 10 cm line as they rate their pain intensity from 0 to 100 in mm. Higher scores represent worse outcome. | 2 years | |
Secondary | Neuropathic Pain Questionnaire | The Neuropathic pain Questionnaire (NPQ) is an assessment instrument for neuropathic pain intensity and quality. It contains 12 items: 10 related to sensations or sensory responses and two related to affect. The items are totaled and rated out of 12, with 12 being in the most neuropathic pain. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01659073 -
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
|
N/A | |
Recruiting |
NCT05914311 -
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
|
N/A | |
Recruiting |
NCT05422456 -
The Turkish Version of Functional Disability Inventory
|
||
Enrolling by invitation |
NCT05422443 -
The Turkish Version of Pain Coping Questionnaire
|
||
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04385030 -
Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
|
N/A | |
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05103319 -
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
|
||
Completed |
NCT03687762 -
Back on Track to Healthy Living Study
|
N/A | |
Completed |
NCT04171336 -
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
|
N/A | |
Completed |
NCT03179475 -
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
|
Phase 4 | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
Recruiting |
NCT06060028 -
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Terminated |
NCT03538444 -
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
|
N/A | |
Not yet recruiting |
NCT05812703 -
Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
|