Posttraumatic Stress Disorder (PTSD)NCT05895006
A Neurosensory Account of Anxiety and Stress (Study 1)
A study testing Alternating Current Stimulation (tACS) and Transcranial Random Noise stimulation (tRNS) in people with Posttraumatic Stress Disorder (PTSD) and Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD. Additionally, the study aims to identify how Transcranial Alternating Current Stimulation (tACS) brain stimulation can modulate and correct neural networks and related emotions of anxious arousal and… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition
- What is being tested?
- 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
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 31 Dec 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed
- With normal or corrected-to-normal vision and normal olfaction
- Between the ages of 18 and 50 years
- Meeting the tACS screening criteria (see List I below; e.g., lack of a serious head injury or loss of consciousness)
- Patients: Diagnosis of PTSD
- Patients: If taking psychotropic medications, medication stability in the past 2 months
- If having mild substance use disorder (for patients) or occasional substance use, abstention from use 48 hours before the experiment.
Who cannot join
- A history of diagnosis for a major medical illness (e.g., cancer, metabolic syndrome, cardiovascular disease, inflammatory disorders) or a neurological disorder (e.g., seizure, stroke, Parkinson's disease).
- Patients: Concurrent Axis I diagnosis (depression, anxiety, and mild substance use disorder are allowed given their high comorbidity with PTSD).
- Healthy controls: A history of diagnosis for a DSM-5 Axis I disorder or current use of psychoactive medications.
- Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior that poses an immediate danger to self or others.
- History of head trauma with unconsciousness (> 5 minutes)
- Report that they regularly drink 3 or more alcoholic beverages a day.
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- Report that they are unable to abstain from substance use (including alcohol, nicotine, cannabis, amphetamines, narcotics, solvents, cocaine, hallucinogens, tranquilizers, barbiturates, etc.) or sleep medication for 48 hours before being scanned.
- Are on calcium channel blockers (e.g., verapamil, nifedipine) or alpha-blockers (e.g., prazosin, terazosin) and are unable to stop these medications for a 48-hour period prior to scanning (to exclude the impact of these medications on the interpretation of fMRI/EEG).
- Failed Urine Drug Screening Test: A rapid urine screening test that utilizes monoclonal antibodies to detect elevated levels of specific drugs (including alcohol, amphetamines, benzodiazepines, barbiturates, cocaine, marijuana, opiates, etc.) in urine (iCup)
- Pregnancy based on urine test. The safety of MR systems has not been established for fetuses
- Having electrically, magnetically, or mechanically activated implants (e.g., cardiac pacemakers), because the electromagnetic fields produced by the MR system may interfere with the operation of these devices.
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, PhD, (713) 486-2700, Jada.Malveaux@uth.tmc.edu
About this study
Official title: Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition and Sensory-Prefrontal-cortex-Amygdala (SPA) Pathology in Posttraumatic Stress Disorder (PTSD) (Aims 1 & 2; Expts. 1a &1b)
This study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD. Additionally, the study aims to identify how Transcranial Alternating Current Stimulation (tACS) brain stimulation can modulate and correct neural networks and related emotions of anxious arousal and hypervigilance, with the goal of assessing tACS brain stimulation technology as a novel intervention for symptoms of anxiety.
Read the detailed description
This study includes experiments 1a \& 1b to address Aims 1 and -- Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition and Sensory-Prefrontal-cortex-Amygdala (SPA) pathology in PTSD. The goal of this study is to develop and test a novel pathophysiology of PTSD by integrating sensory cortical (SC) and amygdala-prefrontal cortex (PFC) dysfunctions into a tripartite Sensory-Prefrontal-Cortex-Amygdala (SPA) model.
The investigators will recruit 80 healthy subjects and 80 patients with PTSD in a randomized, double-blind, controlled design, where they be randomly assigned to 1) Transcranial Alternating Current Stimulation (tACS) at individual alpha peak frequency (active condition); 2) sham control tACS; or 3) active control, which will be transcranial random noise stimulation (tRNS) (random frequency 1-200 Hz). During tACS/sham tACS/tRNS stimulation, stimulation electrodes will be placed inside the holders of an EEG cap attached to the head of the participant. Simultaneous EEG- fMRI recordings during the resting state (in experiment 1a) and during a novelty task (in experiment 1b) will be acquired before and after tACS/tRNS stimulation.
- Conditions
- Posttraumatic Stress Disorder (PTSD), Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition
- Being tested
- Alternating Current Stimulation (tACS), Sham for Transcranial Alternating Current Stimulation (tACS), Transcranial Random Noise stimulation (tRNS)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternating Current Stimulation (tACS)Device
A weak electrical current will be passed through the scalp over targeted cortical regions via a transcranial electrical stimulation system (Soterix Medical, Inc), for a span of 10 to 40 minutes at a time. Participants will receive a 2 milliamp (mA) sinusoidal current oscillating at individual participants' baseline peak alpha frequencies (PAF; 7-13 Hz), which will be determined by a 3-min resting state EEG recording during the setup. Current intensities will be modified to address individual participants' subjective reports of discomfort, with a maximum intensity of 2 mA. Stimulation electrodes will be placed within an EEG cap fitted over the participant's head.
Sham for Transcranial Alternating Current Stimulation (tACS)Device
Stimulation electrodes will be placed on the scalp, but no current will be passed. Stimulation electrodes will be placed within an EEG cap fitted over the participant's head.
Transcranial Random Noise stimulation (tRNS)Device
A weak electrical currents will be passed through the scalp over targeted cortical regions via a transcranial electrical stimulation system (Soterix Medical, Inc), for a span of 10 to 40 minutes at a time. Participants will receive a 2 mA sinusoidal current oscillating at random frequency (1-200 Hz). Current intensities will be modified to address individual participants' subjective reports of discomfort, with a maximum intensity of 2 mA. Stimulation electrodes will be placed within an EEG cap fitted over the participant's head.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Alternating Current Stimulation (tACS) | Experimental | Not described Receives: Device: Alternating Current Stimulation (tACS) |
| Sham for Transcranial Alternating Current Stimulation (tACS) | Sham comparator | Not described Receives: Device: Sham for Transcranial Alternating Current Stimulation (tACS) |
| Active Control - Transcranial Random Noise stimulation (tRNS) | Active comparator | Not described Receives: 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 neural oscillatory activity as assessed by electroencephalogram (EEG) alpha power change
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in cortical activity as assessed by functional magnetic resonance imaging (fMRI) blood-oxygen-level dependent (BOLD) signal change
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Secondary outcomes (3)
Change in salience detection and vigilance behavior as assessed by percent accuracy on an oddball detection task
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in salience detection and vigilance behavior as assessed by reaction time in milliseconds (ms) on an oddball detection task
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in salience detection and vigilance behavior as assessed by skin conductance measured in microsiemens (μS)
Measured: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start5 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- 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
- NCT05895006
- Sponsor's protocol ID
- HSC-MS-23-1106 (study 1)
- Other IDs
- R01MH132209
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition and Sensory-Prefrontal-cortex-Amygdala (SPA) Pathology in Posttraumatic Stress Disorder (PTSD) (Aims 1 & 2; Expts. 1a &1b)
- ClinicalTrials.gov ID
- NCT05895006
- Acronym / sponsor ID
- HSC-MS-23-1106 (study 1)
- Conditions
- Posttraumatic Stress Disorder (PTSD), Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jun 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.
This study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD. Additionally, the study aims to identify how Transcranial Alternating Current Stimulation (tACS) brain stimulation can modulate and correct neural networks and related emotions of anxious arousal and hypervigilance, with the goal of assessing tACS brain stimulation technology as a novel intervention for symptoms of anxiety.
Detailed description
This study includes experiments 1a \& 1b to address Aims 1 and -- Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition and Sensory-Prefrontal-cortex-Amygdala (SPA) pathology in PTSD. The goal of this study is to develop and test a novel pathophysiology of PTSD by integrating sensory cortical (SC) and amygdala-prefrontal cortex (PFC) dysfunctions into a tripartite Sensory-Prefrontal-Cortex-Amygdala (SPA) model.
The investigators will recruit 80 healthy subjects and 80 patients with PTSD in a randomized, double-blind, controlled design, where they be randomly assigned to 1) Transcranial Alternating Current Stimulation (tACS) at individual alpha peak frequency (active condition); 2) sham control tACS; or 3) active control, which will be transcranial random noise stimulation (tRNS) (random frequency 1-200 Hz). During tACS/sham tACS/tRNS stimulation, stimulation electrodes will be placed inside the holders of an EEG cap attached to the head of the participant. Simultaneous EEG- fMRI recordings during the resting state (in experiment 1a) and during a novelty task (in experiment 1b) will be acquired before and after tACS/tRNS stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcranial Alternating Current Stimulation (tACS) | Experimental | Device: Alternating Current Stimulation (tACS) |
| Sham for Transcranial Alternating Current Stimulation (tACS) | Sham comparator | Device: Sham for Transcranial Alternating Current Stimulation (tACS) |
| Active Control - Transcranial Random Noise stimulation (tRNS) | Active comparator | Device: Transcranial Random Noise stimulation (tRNS) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Right-handed
- With normal or corrected-to-normal vision and normal olfaction
- Between the ages of 18 and 50 years
- Meeting the tACS screening criteria (see List I below; e.g., lack of a serious head injury or loss of consciousness)
- Patients: Diagnosis of PTSD
Key exclusion criteria (11 listed)
- A history of diagnosis for a major medical illness (e.g., cancer, metabolic syndrome, cardiovascular disease, inflammatory disorders) or a neurological disorder (e.g., seizure, stroke, Parkinson's disease).
- Patients: Concurrent Axis I diagnosis (depression, anxiety, and mild substance use disorder are allowed given their high comorbidity with PTSD).
- Healthy controls: A history of diagnosis for a DSM-5 Axis I disorder or current use of psychoactive medications.
- Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior that poses an immediate danger to self or others.
- History of head trauma with unconsciousness (> 5 minutes)
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 |
|---|---|---|
| Alternating Current Stimulation (tACS)A weak electrical current will be passed through the scalp over targeted cortical regions via a transcranial electrical stimulation system (Soterix Medical, Inc), for a span of 10 to 40 minutes at a time. Participants will receive a 2 milliamp (mA) sinusoidal current oscillating at individual participants' baseline peak alpha frequencies (PAF; 7-13 Hz), which will be determined by a 3-min resting state EEG recording during the setup. Current intensities will be modified to address individual participants' subjective reports of discomfort, with a maximum intensity of 2 mA. Stimulation electrodes will be placed within an EEG cap fitted over the participant's head. | Device | Transcranial Alternating Current Stimulation (tACS) |
| Sham for Transcranial Alternating Current Stimulation (tACS)Stimulation electrodes will be placed on the scalp, but no current will be passed. Stimulation electrodes will be placed within an EEG cap fitted over the participant's head. | Device | Sham for Transcranial Alternating Current Stimulation (tACS) |
| Transcranial Random Noise stimulation (tRNS)A weak electrical currents will be passed through the scalp over targeted cortical regions via a transcranial electrical stimulation system (Soterix Medical, Inc), for a span of 10 to 40 minutes at a time. Participants will receive a 2 mA sinusoidal current oscillating at random frequency (1-200 Hz). Current intensities will be modified to address individual participants' subjective reports of discomfort, with a maximum intensity of 2 mA. Stimulation electrodes will be placed within an EEG cap fitted over the participant's head. | Device | Active Control - Transcranial Random Noise stimulation (tRNS) |
Primary outcome
Change in neural oscillatory activity as assessed by electroencephalogram (EEG) alpha power change
Time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in cortical activity as assessed by functional magnetic resonance imaging (fMRI) blood-oxygen-level dependent (BOLD) signal change
Time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
3 secondary outcomes
Change in salience detection and vigilance behavior as assessed by percent accuracy on an oddball detection task
Time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in salience detection and vigilance behavior as assessed by reaction time in milliseconds (ms) on an oddball detection task
Time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
Change in salience detection and vigilance behavior as assessed by skin conductance measured in microsiemens (μS)
Time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)
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 12 Sep 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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 Alternating Current Stimulation (tACS) and Transcranial Random Noise stimulation (tRNS) in people with Posttraumatic Stress Disorder (PTSD) and Intrinsic and Novelty-related Sensory Cortical (SC) Disinhibition, 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 7 inclusion and 11 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 12 Sep 2025. 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. Some participants in this study may receive a placebo. 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 neural oscillatory activity as assessed by electroencephalogram (EEG) alpha power change (time frame: baseline (pre-stimulation); immediately post-stimulation (about 10 to 40 minutes after start of stimulation)). 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 12 Sep 2025.