Cognition and Behavior With Sham Accelerated TMS

NCT07397858 | Recruiting

• 1 other identifier: 2375938
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to understand how a person's expectations about treatment can influence their mood, motivation, and reactions to everyday rewards. The study includes young people ages 15-25 who will complete a sham (placebo) version of an accelerated transcranial magnetic stimulation (TMS) treatment. No active brain stimulation is given. The main questions this study aims to answer are:

• Complete baseline clinical assessments and an MRI session
• Undergo five days of accelerated sham TMS (no active brain stimulation is delivered)
• Complete post-treatment MRI and follow-up assessments at 1 week and 4 weeks

Conditions

Healthy Participants

Keywords

TMS; Sham TMS

Outcome Measures

Primary Outcomes (4)

• Accelerated sham TMS feasibility

  Proportion of participants who complete the accelerated sham TMS protocol, defined as completion of all scheduled stimulation sessions. Feasibility will be assessed using session attendance logs and protocol completion records.

  From enrollment to end of study at 5 weeks

• Change in treatment expectancy and beliefs

  Change in treatment expectancy and beliefs score from baseline to end of study at 5 weeks, as measured by the Credibility/Expectancy Questionnaire (CEQ). Outcomes will be quantified as the difference in total CEQ score between time points. CEQ scores range from 1 to 9 for treatment credibility and expectancy, with higher scores indicating greater perceived credibility/ expectancy.

  From enrollment to end of study at 5 weeks

• Change in reward sensitivity

  Change in reward sensitivity will be assessed as the difference in scores from baseline to 5-week follow-up on validated self-report measures, including the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), the Snaith-Hamilton Pleasure Scale (SHAPS), and the Temporal Experience of Pleasure Scale (TEPS). SPSRQ scores range from 0-24 for each subscale, TEPS scores range from 18-108, and SHAPS scores range from 14-56, with higher scores indicating greater sensitivity to reward/punishment, pleasure capacity, and anhedonia, respectively.

  From enrollment to end of study at 5 weeks

• Change in craving and engagement

  Changes in cravings and engagement with reinforcing stimuli will be assessed as the difference in scores from baseline to 5-week follow-up on various self-report measures and tasks. Craving will be assessed using a behavioral craving task, with outcomes quantified as change in task-derived craving ratings or performance metrics from baseline to follow-up. Substance use will additionally be assessed as change in drug use frequency and quantity over the study period.

  From enrollment to end of study at 5 weeks

Secondary Outcomes (4)

• Changes in depressive symptoms

  From enrollment to end of study at 5 weeks

• Changes in mania symptoms

  From enrollment to end of study at 5 weeks

• Changes in suicidality

  From enrollment to end of study at 5 weeks

• Change in quality of life and functioning

  From enrollment to end of study at 5 weeks

Study Arms (1)

Open label sham

OTHER

All study participants will receive sham TMS (no active stimulation will be provided).

Device: Transcranial Magnetic Stimulation Sham

Interventions

Transcranial Magnetic Stimulation Sham DEVICE

All study participants will receive sham TMS (no active stimulation will be provided).

Open label sham

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English speaking
• Able to provide informed consent (and assent if \< 18 years)
• years old

You may not qualify if:

• Unable to consent (due to medical condition, psychosis, substance use, etc)
• Acute suicidal crisis or with active medical illness that would interfere with participation
• Contraindications to receiving MRI as determined by screening questionnaires (Contraindications for MRI include metal in the body related to an injury or surgery, for example, surgical clips, metal fragments in the eyes, or piercings that cannot be removed. Subjects with braces or permanent retainers will not be scanned, because the effects on image signal are not well understood and may affect comparability between subjects and scan sites. Participants will be excluded for major neurological problems, such as seizure disorder, traumatic brain injury with loss of consciousness, or sensory problems that may impair task performance, such as blindness.)
• Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: February 9, 2026
• Study Start: April 11, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)