Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury
NCT ID: NCT03302793
Last Updated: 2019-01-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
12 participants
INTERVENTIONAL
2015-04-30
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects
NCT03302780
Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
NCT04506099
Electromyographic Response to TsDcs in CNSLBP
NCT06712992
Effects of Non Invasive Brain Stimulation During Prolonged Experimental Pain
NCT04246853
Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design
NCT01896453
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BreEStim and tDCS sham, then combined BreEStim and tDCS
BreEStim is voluntary breathing controlled electrical stimulation.
BreEStim
BreEStim will applied for 10 to 20 minutes.
tDCS
tDCS will be applied for 20 minutes.
tDCS sham
Combined BreEStim and tDCS, then BreEStim and tDCS sham
BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.
BreEStim
BreEStim will applied for 10 to 20 minutes.
tDCS
tDCS will be applied for 20 minutes.
tDCS sham
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BreEStim
BreEStim will applied for 10 to 20 minutes.
tDCS
tDCS will be applied for 20 minutes.
tDCS sham
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sheng Li
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sheng Li, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
TIRR
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HSC-MS-14-0564 SCI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.