Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain

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)

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Device: transcranial alternating current stimulation (tACS); Device: Sham; Device: transcranial random noise stimulation (tRNS)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen Li, PhD; Phone Number: (713) 486-2700; Email: Wen.Li.1@uth.tmc.edu
• Study Contact Backup: Name: Jada Malveaux; Phone Number: (713) 486-2700; Email: Jada.Malveaux@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Wen Li, PhD; Phone Number: (713) 486-2700; Email: Wen.Li.1@uth.tmc.edu
      • Contact: Jada Malveaux; Phone Number: (713) 486-2700; Email: Jada.Malveaux@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Meet the MRI / EEG screening criteria
• Fluent in English

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tACS then tRNS then sham	Device: 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; 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; Device: transcranial random noise stimulation (tRNS); Participants will still get stimulation, but at random frequencies between 1 and 200 Hz (instead of targeted alpha waves).
Experimental: tACS then sham then tRNS	Device: 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; 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; Device: transcranial random noise stimulation (tRNS); Participants will still get stimulation, but at random frequencies between 1 and 200 Hz (instead of targeted alpha waves).
Experimental: tRNS then tACS then sham	Device: 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; 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; Device: transcranial random noise stimulation (tRNS); Participants will still get stimulation, but at random frequencies between 1 and 200 Hz (instead of targeted alpha waves).
Experimental: tRNS then sham then tACS	Device: 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; 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; Device: transcranial random noise stimulation (tRNS); Participants will still get stimulation, but at random frequencies between 1 and 200 Hz (instead of targeted alpha waves).
Experimental: Sham then tRNS then tACS	Device: 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; 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; Device: transcranial random noise stimulation (tRNS); Participants will still get stimulation, but at random frequencies between 1 and 200 Hz (instead of targeted alpha waves).
Experimental: Sham then tACS then tRNS	Device: 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; 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; Device: transcranial random noise stimulation (tRNS); Participants will still get stimulation, but at random frequencies between 1 and 200 Hz (instead of targeted alpha waves).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in thalamocortical (TC) connectivity during tonic pressure pain using fMRI	pre-stimulation, post-stimulation (about 30 minutes)
Change in alpha activity during tonic pressure pain using EEG	pre-stimulation, post-stimulation (about 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pre-stimulation, post-stimulation (about 30 minutes)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Wen Li, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: May 5, 2025
• First Submitted That Met QC Criteria: May 5, 2025
• First Posted (Actual): May 13, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Transcranial Alternating Current Stimulation (tACS)
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: HSC-MS-25-0062; 5R01NS129059-03 (U.S. NIH Grant/Contract)

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