Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 1, 2017
CompletedFirst Posted
Study publicly available on registry
October 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
January 24, 2019
CompletedJanuary 24, 2019
January 1, 2019
2.7 years
October 1, 2017
December 17, 2018
January 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Pain as Assessed by Visual Analogue Scale (VAS)
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain.
baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Secondary Outcomes (2)
Electrical Pain Threshold
baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Electrical Sensation Threshold
baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Study Arms (2)
BreEStim and tDCS sham, then combined BreEStim and tDCS
EXPERIMENTALBreEStim is voluntary breathing controlled electrical stimulation.
Combined BreEStim and tDCS, then BreEStim and tDCS sham
EXPERIMENTALBreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.
Interventions
BreEStim will applied for 10 to 20 minutes.
tDCS will be applied for 20 minutes.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TIRR
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 30132010RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sheng Li
- Organization
- UTHealth
Study Officials
- PRINCIPAL INVESTIGATOR
Sheng Li, MD, PhD
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 1, 2017
First Posted
October 5, 2017
Study Start
April 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
January 24, 2019
Results First Posted
January 24, 2019
Record last verified: 2019-01