PainNCT06968689
Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain
A study testing transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) in people with Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess thalamocortical (TC) connectivity during tonic pressure pain, to evaluate alpha activity during tonic pressure pain and to determine pressure pain ratings by using Electroencephalography (EEG), Functional Magnetic Resonance Imaging (fMRI), Transcranial Alternating Current… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 29 Feb 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meet the MRI / EEG screening criteria
- Fluent in English
Who cannot join
- Current or history of major medical, neurological, or psychiatric illness based on self-report
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)
- History of head trauma
- Pregnant or lactating
- Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
- Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)
- Active substance abuse disorders (based on subject self-report)
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 at Houston
Houston, Texas, 77030
Wen Li, PhD, (713) 486-2700, Wen.Li.1@uth.tmc.edu
Jada Malveaux, (713) 486-2700, Jada.Malveaux@uth.tmc.edu
About this study
Official title: Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain - Phase II
The purpose of this study is to assess thalamocortical (TC) connectivity during tonic pressure pain, to evaluate alpha activity during tonic pressure pain and to determine pressure pain ratings by using Electroencephalography (EEG), Functional Magnetic Resonance Imaging (fMRI), Transcranial Alternating Current Stimulation (tACS), sham and Transcranial random noise stimulation (tRNS)
- Conditions
- Pain
- Being tested
- transcranial alternating current stimulation (tACS), Sham, transcranial random noise stimulation (tRNS)
- Keywords
- Transcranial Alternating Current Stimulation (tACS)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial alternating current stimulation (tACS)Device
Participants will get a personalized brain stimulation: a 2 milliampere (mA) oscillating current that matches their natural alpha brain wave frequency (8-12 Hz), determined by a quick 3-minute EEG before the session.
ShamDevice
Active sham stimulation with 60- second -tACS will be applied , then ramp down, and be reintroduced in the last 30 seconds to minimize awareness of the experimental condition
transcranial random noise stimulation (tRNS)Device
Participants will still get stimulation, but at random frequencies between 1 and 200 Hz (instead of targeted alpha waves).
| Study group | Role | What they receive |
|---|---|---|
| tACS then tRNS then sham | Experimental | Not described Receives: Device: transcranial alternating current stimulation (tACS); Device: Sham; Device: transcranial random noise stimulation (tRNS) |
| tACS then sham then tRNS | Experimental | Not described Receives: Device: transcranial alternating current stimulation (tACS); Device: Sham; Device: transcranial random noise stimulation (tRNS) |
| tRNS then tACS then sham | Experimental | Not described Receives: Device: transcranial alternating current stimulation (tACS); Device: Sham; Device: transcranial random noise stimulation (tRNS) |
| tRNS then sham then tACS | Experimental | Not described Receives: Device: transcranial alternating current stimulation (tACS); Device: Sham; Device: transcranial random noise stimulation (tRNS) |
| Sham then tRNS then tACS | Experimental | Not described Receives: Device: transcranial alternating current stimulation (tACS); Device: Sham; Device: transcranial random noise stimulation (tRNS) |
| Sham then tACS then tRNS | Experimental | Not described Receives: Device: transcranial alternating current stimulation (tACS); Device: Sham; Device: transcranial random noise stimulation (tRNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thalamocortical (TC) connectivity during tonic pressure pain using fMRI
Measured: pre-stimulation, post-stimulation (about 30 minutes)
Change in alpha activity during tonic pressure pain using EEG
Measured: pre-stimulation, post-stimulation (about 30 minutes)
Secondary outcomes (1)
Change in pain as assessed by the Visual Analog Scale (VAS)
The VAS is scored from 0 = no pain; 10 = the most intense pain tolerable, higher number indicating more pain
Measured: pre-stimulation, post-stimulation (about 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Li, The University of Texas Health Science Center, Houston
- Investigators
- Wen Li, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968689
- Sponsor's protocol ID
- HSC-MS-25-0062
- Other IDs
- 5R01NS129059-03
- Status last verified
- Feb 2026
- First submitted
- 5 May 2025
- Last updated
- 2 Mar 2026
- Results posted
- 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain - Phase II
- ClinicalTrials.gov ID
- NCT06968689
- Acronym / sponsor ID
- HSC-MS-25-0062
- Conditions
- Pain
- Keywords
- Transcranial Alternating Current Stimulation (tACS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 13 May 2025 (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 purpose of this study is to assess thalamocortical (TC) connectivity during tonic pressure pain, to evaluate alpha activity during tonic pressure pain and to determine pressure pain ratings by using Electroencephalography (EEG), Functional Magnetic Resonance Imaging (fMRI), Transcranial Alternating Current Stimulation (tACS), sham and Transcranial random noise stimulation (tRNS)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| tACS then tRNS then sham | Experimental | Device: transcranial alternating current stimulation (tACS), Device: Sham, Device: transcranial random noise stimulation (tRNS) |
| tACS then sham then tRNS | Experimental | Device: transcranial alternating current stimulation (tACS), Device: Sham, Device: transcranial random noise stimulation (tRNS) |
| tRNS then tACS then sham | Experimental | Device: transcranial alternating current stimulation (tACS), Device: Sham, Device: transcranial random noise stimulation (tRNS) |
| tRNS then sham then tACS | Experimental | Device: transcranial alternating current stimulation (tACS), Device: Sham, Device: transcranial random noise stimulation (tRNS) |
| Sham then tRNS then tACS | Experimental | Device: transcranial alternating current stimulation (tACS), Device: Sham, Device: transcranial random noise stimulation (tRNS) |
| Sham then tACS then tRNS | Experimental | Device: transcranial alternating current stimulation (tACS), Device: Sham, Device: transcranial random noise stimulation (tRNS) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meet the MRI / EEG screening criteria
- Fluent in English
Key exclusion criteria (7 listed)
- Current or history of major medical, neurological, or psychiatric illness based on self-report
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)
- History of head trauma
- Pregnant or lactating
- Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
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 |
|---|---|---|
| transcranial alternating current stimulation (tACS)Participants will get a personalized brain stimulation: a 2 milliampere (mA) oscillating current that matches their natural alpha brain wave frequency (8-12 Hz), determined by a quick 3-minute EEG before the session. | Device | Sham then tACS then tRNS, Sham then tRNS then tACS, tACS then sham then tRNS, tACS then tRNS then sham, tRNS then sham then tACS, tRNS then tACS then sham |
| ShamActive sham stimulation with 60- second -tACS will be applied , then ramp down, and be reintroduced in the last 30 seconds to minimize awareness of the experimental condition | Device | Sham then tACS then tRNS, Sham then tRNS then tACS, tACS then sham then tRNS, tACS then tRNS then sham, tRNS then sham then tACS, tRNS then tACS then sham |
| transcranial random noise stimulation (tRNS)Participants will still get stimulation, but at random frequencies between 1 and 200 Hz (instead of targeted alpha waves). | Device | Sham then tACS then tRNS, Sham then tRNS then tACS, tACS then sham then tRNS, tACS then tRNS then sham, tRNS then sham then tACS, tRNS then tACS then sham |
Primary outcome
Change in thalamocortical (TC) connectivity during tonic pressure pain using fMRI
Time frame: pre-stimulation, post-stimulation (about 30 minutes)
Change in alpha activity during tonic pressure pain using EEG
Time frame: pre-stimulation, post-stimulation (about 30 minutes)
1 secondary outcome
Change in pain as assessed by the Visual Analog Scale (VAS)
Time frame: pre-stimulation, post-stimulation (about 30 minutes)
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 2 Mar 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.
Wen Li, PhD 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 transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) in people with Pain, 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 2 inclusion and 7 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 2 Mar 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 Wen Li, PhD ((713) 486-2700, Wen.Li.1@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in thalamocortical (TC) connectivity during tonic pressure pain using fMRI (time frame: pre-stimulation, post-stimulation (about 30 minutes)). 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 2 Mar 2026.