- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02006433
Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury With Deep Brain Stimulation
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami Hospital
-
Miami, Florida, United States, 33136
- Va Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 22-60 years of age
- Level of injury at or above T12
- Neuropathic pain at or below the level of injury, as determined based on pain in an area with neurological deficit and described as burning, shooting, electric, stinging etc.
- The injury must have occurred at least 1 year prior to entering the study and participants must have experienced chronic pain for a minimum of six months.
- The injury level must be at or above T12, and the disability must have a grade on the American Spinal Injury Association Impairment Scale (AIS) of ASIA-A, ASIA-B, ASIA-C or ASIA-D as determined by a qualified examiners.
- Autonomic dysreflexia can be present, but is not a requirement. This is defined as a rise of systolic pressure by more than 30 mmHg during noxious skin stimulation or when the bladder or bowel is full, or apparently spontaneously over a period of minutes.
- Pain (neuropathic) of moderate severity or greater is present, when the patient is taking medication, with a score of at least 4 on a numerical rating scale (range of 0 to 10).
- Treatment with at least two of the following drug classes must have failed to give satisfactory pain relief within the last two years: anticonvulsants e.g., pregabalin, gabapentin); antidepressants (e.g., trazodone, amitriptyline); NSAIDS (e.g., ibuprofen). In addition, at least one of the following must have proved ineffective: exercise-based rehabilitation, massage therapy using a variety of methods, acupuncture using pressure, needles, heat, or electrical stimulation on specific points on the body and psychological interventions such as cognitive therapy.
- The subject must be taking pain medication to maintain a stable level of medication from 4 weeks before surgery to 12 weeks after (the primary endpoint), except on the day of surgery.
- Participants on medications for other conditions, such as diabetes, will be considered as candidates for this study. The dose will be monitored throughout the trial. (They will be excluded if the drug is being used to treat epilepsy, Parkinson's diseases, or other brain degenerative diseases.)
- The subject must be willing to comply with the protocol including all scheduled visits.
- Literate at 8th grade level or above.
- Subject must provide a letter of clearance for the DBS surgery from primary care physician
Exclusion Criteria for Admission to study:
- Unable to give informed consent
- Prisoner or ward of the state
- Pregnancy
- Prior history of abusing nonprescribed drugs
- Recent (one-year) history of alcohol abuse
- ASIA motor exam unobtainable
- History of cardiac arrhythmia
- Renal disease, heart disease or uncontrolled hypertension (except due to autonomic dysreflexia), liver disease or hepatic cirrhosis
- Active major medical or psychiatric illness
- Significant post-traumatic encephalopathy from head trauma sustained at SCI
- Languages without local expertise
- Pain is only nociceptive, or due to muscle spasms
Exclusion Criteria for Treatment/Intervention procedure:
- Coagulopathy requiring anticoagulation therapy
- Thrombocytopenia or platelet dysfunction
- Peripheral vascular disease
- Comorbid neurological diseases or disorders, including a history of seizures
- Active systemic infection or concurrent immunosuppressive therapy
- Existing implantable cardiac pacemaker, defibrillator,or neurostimulator
- Requiring short-wave or microwave diathermy treatment
- Inability to cooperate
- Any contraindication to MRI studies (All future MRIs, with the exception of brain MRIs, are excluded.)
- Adverse reaction to stimulation (such as inability to stimulate at analgesic levels without causing clinical hypertension or hypotension) or allergy or hypersensitivity to any materials of the neurostimulation system
- Depression, as defined by a Beck Depression Inventory (BDI-1a) score above 30.
- Subjects with any clinically significant abnormality, not expected on the basis of age (age-related), that is seen in magnetic resonance imaging (MRI).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deep Brain Stimulation
Deep brain stimulation (DBS) for the alleviation of chronic neuropathic pain in patients with spinal cord injury (SCI). The stimulation will be applied bilaterally or unilaterally in the midbrain periaqueductal/periventricular gray region (PAG/PVG). Extended participation in the study, which will last approximately 2 more years, precisely 104 weeks.The purpose of this extended portion of the study is to obtain long-term follow-up information on safety and efficacy, in subjects that have opted to receive continuing brain stimulation. Investigators label weeks in terms of original enrollment. Thus the surgery occurs in weeks 7 and 8 and the original study finishes in week 52, with the extension lasting from week 53 to week 156. |
Local anesthesis, MRI and CT scan of the brain followed by implantation of the stimulation device
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: Baseline, up to 52 weeks
|
Neuropathic Pain Symptom Inventory (NPSI) is a 12 item questionnaire with each question scored form 0-10 with the highest score indicating greater pain
|
Baseline, up to 52 weeks
|
Change in Pain as measured by Multidimensional pain Inventory (MPI-SCI)
Time Frame: Baseline, up to 52 weeks
|
Multidimensional pain Inventory (MPI-SCI) is a self-report questionnaire consisting of 50 items, each questioned scored from 0-6, with the higher score being the greatest impact of pain on an individuals daily life.
|
Baseline, up to 52 weeks
|
Change in Pain as measured by the Basic Pain Data Set
Time Frame: Baseline, up to 52 weeks
|
The Basic Pain Data set is a 4 question assessing change in pain in the past week using 0-6 scale on each item with the higher score indicating greater pain intensity
|
Baseline, up to 52 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan R Jagid, M.D., University of Miami
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20120429
- W81XWH-12-1-0559 (Other Grant/Funding Number: Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Deep Brain Stimulation
-
Abbott Medical DevicesTerminatedDepressive Disorder, Major | Unipolar DepressionUnited States, Canada, United Kingdom
-
Zhiqi MaoRecruitingParkinson's Disease | Executive Function | Electroencephalogram | Functional Near - Infrared SpectroscopyChina
-
Ali Rezai, MDCompleted
-
University Hospital Inselspital, BerneCompletedMovement Disorder | Urinary Tract DiseaseSwitzerland
-
University of MinnesotaRecruitingParkinson DiseaseUnited States
-
NewronikaTerminatedParkinson DiseaseItaly
-
University of Sao Paulo General HospitalUnknownCerebellar AtaxiaBrazil
-
Butler HospitalMedtronicCompletedObsessive-Compulsive DisorderUnited States
-
Boston Scientific CorporationCompletedParkinson's DiseaseUnited States
-
Qilu Hospital of Shandong UniversityRecruiting