Clinical trial NCT03302793: Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury
Official title: Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain as Assessed by Visual Analogue Scale (VAS)
timeFrame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Secondary outcomes:
measure: Electrical Pain Threshold
timeFrame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
measure: Electrical Sensation Threshold
timeFrame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Other outcomes:
Locations:
city: Houston
country: United States
facility: TIRR
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li S, Stampas A, Frontera J, Davis M, Li S. Combined transcranial direct current stimulation and breathing-controlled electrical stimulation for management of neuropathic pain after spinal cord injury. J Rehabil Med. 2018 Sep 28;50(9):814-820. doi: 10.2340/16501977-2379.