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

NCT02006433 | Completed DMC FDA Device

• 2 other identifiers: 20120429W81XWH-12-1-0559
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain; Autonomic Dysreflexia

Outcome Measures

Primary Outcomes (3)

• Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI)

  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)

  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

  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

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

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

Interventions

Deep Brain Stimulation DEVICE

Local anesthesis, MRI and CT scan of the brain followed by implantation of the stimulation device

Also known as: The Medtronic Models 3387 and 3389 DBS Leads neurostimulation system for deep brain stimulation.

Deep Brain Stimulation

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Coagulopathy requiring anticoagulation therapy
• Thrombocytopenia or platelet dysfunction
• Peripheral vascular disease

Sponsors & Collaborators

• Jonathan Jagid: lead
• United States Department of Defense: collaborator

Study Sites (2)

University of Miami Hospital

Miami, Florida, 33136, United States

Location

VA Medical Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Pain; Autonomic Dysreflexia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Trauma, Nervous System

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jonathan R Jagid, M.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurological Surgery and Neurology

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: December 10, 2013
• Study Start: December 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)