tACS for Neuropathic Pain Management After SCI

tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments

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.

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain Management
• Intervention / Treatment: Device: tACS Sham; Device: tACS 10Hz; Device: tACS 20Hz

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shengai Li, MS; Phone Number: 713-797-7561; Email: shengai.li@uth.tmc.edu
• Study Contact Backup: Name: Sheng Li, MD, Ph.D; Phone Number: (713) 797-7125; Email: sheng.li@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center
      • Contact: Sheng Li, MD, PhD; Phone Number: (713) 797-7125; Email: sheng.li@uth.tmc.edu
      • Contact: Shengai Li, MS; Phone Number: 713-797-7561; Email: shengai.li@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion/exclusion criteria for SCI subjects

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order; 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.; 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.; 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; 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.; 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.; 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; 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scale (visual analogue scale, VAS) measurement	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."	Change of VAS 5 minutes before and after the tACS intervention will be measured.
Heart rate variability (HRV) measurement	Heart rate variability (HRV) is the fluctuation in the time intervals between adjacent heartbeats (1). HRV indexes neurocardiac function and is generated by heart-brain interactions and dynamic non-linear autonomic nervous system (ANS) processes. HRV will be used as a surrogate assessment for autonomic nerve system	Change of HRV 10-15 minutes before and after the tACS intervention will be measured.

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sheng Li, MD, Ph.D, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Neuropathic Pain; tACS
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia
• Other Study ID Numbers: HSC-MS-22-0046 (Experiment 2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No