Cognition and Behavior With Sham Accelerated TMS
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-25
SponsorUniversity of California, Davis
About this trial
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:
1. Do expectancy and treatment beliefs change during and after an accelerated sham TMS schedule? 2. Do these expectations influence mood, reward processing, or craving? 3. Does a more intensive schedule of sham sessions lead to different expectancy effects than a slower, once-daily schedule?
Participants will:
* 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English speaking
Able to provide informed consent (and assent if < 18 years)
15-25 years old
Slight-to-severe symptoms of depression
Disqualifiers
Past exposure to Transcranial Magnetic Stimulation
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.)
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Magnetic Stimulation Sham
DeviceAll study participants will receive sham TMS (no active stimulation will be provided).
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Open label shamOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to end of study at 5 weeks2
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.
Time frame
From enrollment to end of study at 5 weeks3
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.
Time frame
From enrollment to end of study at 5 weeks4
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.
Time frame
From enrollment to end of study at 5 weeksSecondary outcomes
1
Changes in depressive symptoms
Change in depressive symptoms will be measured as the difference in total score from baseline to 5-week follow-up on the Montgomery-Asberg Depression Rating Scale (MADRS). MADRS scores range from 0-60, with higher scores indicating greater depressive symptom severity.
Time frame
From enrollment to end of study at 5 weeks2
Changes in mania symptoms
Change in mania symptoms will be measured as the difference in total score from baseline to 5-week follow-up on the Young Mania Rating Scale (YMRS). YMRS scores range from 0-60, with higher scores indicating greater manic symptom severity.
Time frame
From enrollment to end of study at 5 weeks3
Changes in suicidality
Suicidality will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS), with changes evaluated based on trajectories and patterns of ideation and behavior responses from baseline to the 5-week follow-up. Higher response levels reflect greater suicidality symptom severity.
Time frame
From enrollment to end of study at 5 weeks4
Change in quality of life and functioning
Change from baseline in quality of life and functional outcomes, assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), a standardized self-report measure evaluating satisfaction and functioning across multiple life domains. Q-LES-Q-SF scores range from 14-70, with higher scores indicating greater quality of life and satisfaction.
Time frame
From enrollment to end of study at 5 weeksSponsors and contacts
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Source ClinicalTrials.gov