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

NCT ID: NCT02006433

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: DEVICE

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

Interventions

Deep Brain Stimulation

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

Intervention Type: DEVICE

Other Intervention Names

The Medtronic Models 3387 and 3389 DBS Leads neurostimulation system for deep brain stimulation.

Eligibility Criteria

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

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

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).

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Jonathan Jagid

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Jagid

Associate Professor of Neurological Surgery and Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jonathan R Jagid, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Hospital

Miami, Florida, United States

VA Medical Center

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

W81XWH-12-1-0559

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20120429

Identifier Type: -

Identifier Source: org_study_id