Clincosm LogoSign in Get a demo

Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury With Deep Brain Stimulation

Sponsor
Jonathan Jagid (Other)
Overall Status
Completed
CT.gov ID
NCT02006433
Collaborator
United States Department of Defense (U.S. Fed)
4
Enrollment
2
Locations
1
Arm
45
Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to determine if DBS is a feasible, safe and effective therapy for pain and autonomic dysreflexia after spinal cord injury.

Condition or Disease Intervention/Treatment Phase
  • Device: Deep Brain Stimulation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury With Deep Brain Stimulation
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

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.

Device: Deep Brain Stimulation
Local anesthesis, MRI and CT scan of the brain followed by implantation of the stimulation device
Other Names:
  • The Medtronic Models 3387 and 3389 DBS Leads neurostimulation system for deep brain stimulation.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI) [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

    2. Change in Pain as measured by Multidimensional pain Inventory (MPI-SCI) [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.

    3. Change in Pain as measured by the Basic Pain Data Set [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age 22-60 years of age

    2. Level of injury at or above T12

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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).

    8. 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.

    9. 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.

    10. 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.)

    11. The subject must be willing to comply with the protocol including all scheduled visits.

    12. Literate at 8th grade level or above.

    13. Subject must provide a letter of clearance for the DBS surgery from primary care physician

    Exclusion Criteria for Admission to study:

    1. Unable to give informed consent

    2. Prisoner or ward of the state

    3. Pregnancy

    4. Prior history of abusing nonprescribed drugs

    5. Recent (one-year) history of alcohol abuse

    6. ASIA motor exam unobtainable

    7. History of cardiac arrhythmia

    8. Renal disease, heart disease or uncontrolled hypertension (except due to autonomic dysreflexia), liver disease or hepatic cirrhosis

    9. Active major medical or psychiatric illness

    10. Significant post-traumatic encephalopathy from head trauma sustained at SCI

    11. Languages without local expertise

    12. Pain is only nociceptive, or due to muscle spasms

    Exclusion Criteria for Treatment/Intervention procedure:

    1. Coagulopathy requiring anticoagulation therapy

    2. Thrombocytopenia or platelet dysfunction

    3. Peripheral vascular disease

    4. Comorbid neurological diseases or disorders, including a history of seizures

    5. Active systemic infection or concurrent immunosuppressive therapy

    6. Existing implantable cardiac pacemaker, defibrillator,or neurostimulator

    7. Requiring short-wave or microwave diathermy treatment

    8. Inability to cooperate

    9. Any contraindication to MRI studies (All future MRIs, with the exception of brain MRIs, are excluded.)

    10. 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

    11. Depression, as defined by a Beck Depression Inventory (BDI-1a) score above 30.

    12. Subjects with any clinically significant abnormality, not expected on the basis of age (age-related), that is seen in magnetic resonance imaging (MRI).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Hospital Miami Florida United States 33136
    2 VA Medical Center Miami Florida United States 33136

    Sponsors and Collaborators

    • Jonathan Jagid
    • United States Department of Defense

    Investigators

    • Principal Investigator: Jonathan R Jagid, M.D., University of Miami

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonathan Jagid, Associate Professor of Neurological Surgery and Neurology, University of Miami
    ClinicalTrials.gov Identifier:
    NCT02006433
    Other Study ID Numbers:
    • 20120429
    • W81XWH-12-1-0559
    First Posted:
    Dec 10, 2013
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Autonomic Dysreflexia

    Study Results

    No Results Posted as of Oct 8, 2020