Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial alternating current stimulation (tACS), Sham, transcranial random noise stimulation (tRNS).
- Who it may be relevant to
- Registry conditions: Pain. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Spatiotemporal Thalamocortical Alterations Underlie Experimental and Chronic Pain - Phase II
Overview
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)
Interventions
- 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).
Primary outcome measures
- 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)]
Secondary outcome measures (1)
- Change in pain as assessed by the Visual Analog Scale (VAS) [Time frame: pre-stimulation, post-stimulation (about 30 minutes)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT06968689 · HSC-MS-25-0062 · 5R01NS129059-03