Neuropathic Pain ManagementNCT06029075

tACS for Neuropathic Pain Management After SCI

A study testing tACS 10Hz and tACS 20Hz in people with Neuropathic Pain Management, run by The University of Texas Health Science Center, Houston at 1 site in United States.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Neuropathic Pain Management
What is being tested?: tACS 10Hz and tACS 20Hz
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2025to 31 Mar 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

has neuropathic pain after traumatic spinal cord injury or amputation or brain injury;
has chronic pain, >3 months;
is between 18 to 75 years of age;
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

Who cannot join

are 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 metal implants or supplemental oxygen;
have amputation in their arm(s);
fail to have a motor contraction in the arm muscles with TMS;
are not able to follow commands, or to give consent;

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have asthma or other pulmonary disease;
are not medically stable;
have preexisting psychiatric disorders;
alcohol or drug abuse.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sheng Li, MD, Ph.D contact

(713) 797-7125

sheng.li@uth.tmc.edu

Shengai Li, MS contact

713-797-7561

shengai.li@uth.tmc.edu

United States1 site, 1 recruiting

The University of Texas Health Science Center
Houston, Texas, 77030
Sheng Li, MD, PhD, (713) 797-7125, sheng.li@uth.tmc.edu
Shengai Li, MS, 713-797-7561, shengai.li@uth.tmc.edu
Recruiting

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About this study

Official title: 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.

Conditions: Neuropathic Pain Management
Being tested: tACS Sham, tACS 10Hz, tACS 20Hz
Keywords: tACS, Neuropathic Pain
Medical subject headings: Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tACS ShamDevice
Sham tACS will applied to the brain through the scalp for 20 minutes.
tACS 10HzDevice
10Hz tACS will applied to the brain through the scalp for 20 minutes.
tACS 20HzDevice
20Hz tACS will applied to the brain through the scalp for 20 minutes.

Study groups in NCT06029075
Study group	Role	What they receive
"tACS Sham, tACS 10Hz, tACS 20Hz" experimental order	Experimental	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. Receives: Device: tACS Sham; Device: tACS 10Hz; Device: tACS 20Hz
"HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order	Experimental	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. Receives: Device: tACS Sham; Device: tACS 10Hz; Device: tACS 20Hz
"HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order	Experimental	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. Receives: Device: tACS Sham; Device: tACS 10Hz; Device: tACS 20Hz

What is being measured

The primary outcome is the main question the study is designed to answer.

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."
Measured: 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
Measured: Change of HRV 10-15 minutes before and after the tACS intervention will be measured.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202531 Mar 2028

First posted8 Sep 2023
Study start1 Sep 2025
Primary completion30 Sep 2027 (estimated)
Study completion31 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neuropathic Pain ManagementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 14 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06029075
Sponsor's protocol ID: HSC-MS-22-0046 (Experiment 2)
Status last verified: May 2026
First submitted: 10 May 2023
Last updated: 3 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Interested in taking part?

Sheng Li, MD, Ph.D

(713) 797-7125

sheng.li@uth.tmc.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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