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Purpose

The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for neuropathic pain management in people after spinal cord injury.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

A patient who 1. has neuropathic pain after traumatic spinal cord injury or amputation or brain injury; 2. has chronic pain, >3 months; 3. is between 18 to 75 years of age; 4. 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. NOTE: we plan to begin the study with the spinal cord injury (SCI) subject population as a cohort first, then expand to other subject populations

Exclusion Criteria

Patients will be excluded if they 1. are currently adjusting oral pain medications for their neuropathic pain; 2. have pain, but not neuropathic, e.g., from inflammation at the incision wound of the residual limb or neuroma; 3. have a pacemaker metal implants or supplemental oxygen; 4. have amputation in their arm(s); 5. fail to have a motor contraction in the arm muscles with TMS; 6. are not able to follow commands, or to give consent; 7. have asthma or other pulmonary disease; 8. are not medically stable; 9. have preexisting psychiatric disorders; 10. alcohol or drug abuse.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
"tACS Sham, tACS 10Hz, tACS 20Hz" experimental order 		1. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns. 2. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. 3. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.
  • Device: tACS Sham
    Sham tACS will applied to the brain through the scalp for 20 minutes.
  • Device: tACS 10Hz
    10Hz tACS will applied to the brain through the scalp for 20 minutes.
  • Device: tACS 20Hz
    20Hz tACS will applied to the brain through the scalp for 20 minutes.
Experimental
"HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order 		1. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns. 2. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. 3. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
  • Device: tACS Sham
    Sham tACS will applied to the brain through the scalp for 20 minutes.
  • Device: tACS 10Hz
    10Hz tACS will applied to the brain through the scalp for 20 minutes.
  • Device: tACS 20Hz
    20Hz tACS will applied to the brain through the scalp for 20 minutes.
Experimental
"HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order 		1. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. 2. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns. 3. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
  • Device: tACS Sham
    Sham tACS will applied to the brain through the scalp for 20 minutes.
  • Device: tACS 10Hz
    10Hz tACS will applied to the brain through the scalp for 20 minutes.
  • Device: tACS 20Hz
    20Hz tACS will applied to the brain through the scalp for 20 minutes.

Recruiting Locations

The University of Texas Health Science Center
Houston, Texas 77030
Contact:
Sheng Li, MD, PhD
(713) 797-7125
sheng.li@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Sheng Li, MD, Ph.D
(713) 797-7125
sheng.li@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.