Sham-Controlled Rapid-Acting Neuromodulation for Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Davis
About this trial
The goal of this study is to learn whether 5 days of accelerated intermittent theta burst stimulation (iTBS), a rapid form of transcranial magnetic stimulation (TMS), which is a non-invasive procedure that uses magnetic fields to stimulate brain activity, works to treat depression in adults.
The main questions it aims to answer are:
* Does accelerated iTBS reduce depressive symptoms compared to sham (placebo) stimulation? * Are there measurable brain, biological, and digitally measured emotion changes associated with treatment response?
Participants will:
* Be randomly assigned to receive either active iTBS or sham stimulation * Receive 10 stimulation sessions per day for 5 consecutive days (total of 50 sessions) * Complete MRI brain scans and EEG recordings before and after treatment * Provide blood and saliva samples to measure biological markers * Complete depression rating scales and questionnaires at baseline, during treatment, and at follow-up visits * Use a secure mobile app to record brief facial and vocal samples during the 5-day treatment and at follow-up visits * Return for follow-up visits at 1 week and at 1, 3, 6, and 12 months after treatment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English speaking
Able to provide informed consent
18-65 years old
Meets MDD criteria per the Mini International Neuropsychiatric Interview (MINI)
Disqualifiers
Unable to consent (due to medical condition, acute psychosis, substance use, etc)
Use of benzodiazepines or medications that would interfere with TMS treatment as per PI discretion
Active substance use or severe substance use that in the opinion of the PI would interfere with study participation
Untreated, active psychosis
Trial design
Design model
Parallel
Treatments tested in this trial
intermittent theta burst stimulation
DeviceThe TMS protocol involves delivering sessions of intermittent theta burst stimulation (iTBS) of 60 cycles of 10 bursts of three pulses at 50 Hz delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation sessions will be delivered hourly. Ten sessions will be applied per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses in total). Stimulation will be delivered at 90% resting motor threshold (rMT). For safety, stimulation will never be delivered above 120% rMT. Participants assigned to the sham group will receive treatment using a sham TMS coil.
Sham (No Treatment)
DeviceParticipants assigned to the sham group will receive treatment using a sham TMS coil. This coil looks and sounds similar to the active coil but does not deliver magnetic pulses to the brain.
Treatment groups
264 Participants
are divided into 2 treatment groupsGroup A: Active iTBSExperimental treatment 1 intervention
Group B: Sham iTBSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Montgomery-Åsberg Depression Rating Scale (MADRS)
Change in depressive symptoms (MADRS scores)
Time frame
Baseline through study completion, 1 yearSecondary outcomes
1
Change in large-scale brain network connectivity measured by fMRI
Change in resting-state functional connectivity within and between large-scale brain networks associated with depression, including the default mode network, salience network, and central executive network.
Time frame
Baseline through study completion, 1 year2
Change in electroencephalography (EEG) spectral power
Change in resting-state electroencephalography (EEG) spectral power across frequency bands (delta, theta, alpha, beta, and gamma).
Time frame
Baseline through study completion, 1 year3
Change in facial and vocal affective expression
Change in multimodal affective dynamics derived from combined facial and vocal recordings using machine learning-based analysis to generate composite measures of emotional expression and variability.
Time frame
Baseline through study completion, 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: