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.
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
- Are there results?
- Not yet: the study is under way
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.
United States1 site, 1 recruiting
- 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
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 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.
- 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.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Li, The University of Texas Health Science Center, Houston
- Investigators
- Sheng Li, MD, Ph.D, Principal investigator, The University of Texas Health Science Center, Houston
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments
- ClinicalTrials.gov ID
- NCT06029075
- Acronym / sponsor ID
- HSC-MS-22-0046 (Experiment 2)
- Conditions
- Neuropathic Pain Management
- Keywords
- tACS, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order | Experimental | Device: tACS Sham, Device: tACS 10Hz, Device: tACS 20Hz1. 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. |
| "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order | Experimental | Device: tACS Sham, Device: tACS 10Hz, Device: tACS 20Hz1. 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. |
| "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order | Experimental | Device: tACS Sham, Device: tACS 10Hz, Device: tACS 20Hz1. 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tACS ShamSham tACS will applied to the brain through the scalp for 20 minutes. | Device | "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order, "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order, "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order |
| tACS 10Hz10Hz tACS will applied to the brain through the scalp for 20 minutes. | Device | "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order, "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order, "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order |
| tACS 20Hz20Hz tACS will applied to the brain through the scalp for 20 minutes. | Device | "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order, "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order, "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order |
Primary outcome
Pain scale (visual analogue scale, VAS) measurement
Time frame: Change of VAS 5 minutes before and after the tACS intervention will be measured.
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."
Heart rate variability (HRV) measurement
Time frame: Change of HRV 10-15 minutes before and after the tACS intervention will be measured.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheng Li, MD, Ph.D principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Li, MD, Ph.D ((713) 797-7125, sheng.li@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale (visual analogue scale, VAS) measurement (time frame: Change of VAS 5 minutes before and after the tACS intervention will be measured.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.