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

Completed · Not applicable · Has a placebo group

Conditions studied: Pain Management

In brief

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.

Key facts

Study ID

NCT03302793

Run by

The University of Texas Health Science Center, Houston

People needed

12

Starts

2015-04-01

Expected to finish

2017-12-01

Last updated by the study team

2019-01-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• TIRR — Houston, Texas, United States

Full record on ClinicalTrials.gov

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