Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain

NCT06968689 | Recruiting FDA Device

• 2 other identifiers: HSC-MS-25-00625R01NS129059-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 Stimulation (tACS), sham and Transcranial random noise stimulation (tRNS)

Conditions

Pain

Keywords

Transcranial Alternating Current Stimulation (tACS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in pain as assessed by the Visual Analog Scale (VAS)

  pre-stimulation, post-stimulation (about 30 minutes)

Study Arms (6)

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)

Interventions

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.

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

Sham DEVICE

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

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) DEVICE

Participants will still get stimulation, but at random frequencies between 1 and 200 Hz (instead of targeted alpha waves).

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wen Li, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Li, PhD

CONTACT

(713) 486-2700; Wen.Li.1@uth.tmc.edu

Jada Malveaux

CONTACT

(713) 486-2700; Jada.Malveaux@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)