Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury

The University of Texas System (UT)

Status

Completed

Conditions

Pain Management

Treatments

Device: tDCS sham

Device: BreEStim

Device: tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT03302793

HSC-MS-14-0564 SCI

Details and patient eligibility

About

This study looks at the effect of combined breathing-controlled electrical stimulation (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the study in a population of spinal cord injury patients. Note that this study will also enroll healthy volunteers, brain injury patients, and amputation patients and that this study as applied to these other populations will be covered in separate ClinicalTrials.gov records.

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

between 18 and 75 years
male and female subjects
has neuropathic pain after traumatic spinal cord injury
has chronic pain, >3 months
is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)

Exclusion criteria

currently adjusting oral pain medications for their neuropathic pain
have pain, but not neuropathic (e.g., from inflammation at the incision wound of the residual limb or neuroma)
have a pacemaker, or other metal and/or implanted devices
have amputation in their arm(s)
have spinal cord injury (SCI) involving impairment of arms
have cognitive impairment from brain injury or are not able to follow commands, or to give consent
have asthma or other pulmonary disease
are not medically stable
have preexisting psychiatric disorders
alcohol or drug abuse
have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.
Mini-mental state examination (MMSE), a brief 30-point questionnaire test that is commonly used in the literature, will be used to screen for cognitive impairment. A brain injury patient with a score of 24 or lower on MMSE will be excluded.