UCSD Interventional Psychiatry
San Diego, California, 92127, United States
Location status: Recruiting
Location contact
Edith Jimenez
CONTACT
UCSD Interventional Psychiatry Clinic
CONTACT
NCT Number: NCT07217223
The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability and feasibility of at-home transcranial direct current stimulation (tDCS) as a treatment for depression, particularly in cases where patients have not responded well to traditional therapies. Treatment will be delivered over a 2-week period with daily weekday treatments i.e., five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours a day. Participants will self-administer treatment at home under direct remote supervision. Pre- and post- treatment neurophysiological biomarkers sessions will also be carried out. The study aims to examine changes in mood, brain activity, and related clinical outcomes before, during, and after treatment, with the goal to provide more information that can be used for future studies.
PLEASE NOTE: THERE WILL BE 4 APPOINTMENTS THAT MUST OCCUR IN PERSON IN SAN DIEGO, CA.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
San Diego, California, 92127, United States
Location status: Recruiting
Edith Jimenez
CONTACT
UCSD Interventional Psychiatry Clinic
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
tDCS will be self-administered at home under the supervision of a trained clinical research coordinator using the Soterix Medical mini-CT device with remote monitoring via a secure videoconferencing platform (e.g., Microsoft Teams).The device is designed for safe, remote tDCS delivery. Participants will be treated using a stimulation at 2 mA, with a 30-second ramp-up and ramp-down phase.
Time frame: From baseline clinical assessment prior to treatment to 12 weeks after last treatment.
Recruitment rate will be measured as the number of patients enrolled by the conclusion of the study, reported as a whole number.
Time frame: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.
Retention rate will be measured as the percentage of enrolled patients who complete all study visits, reported as a percentage.
Time frame: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.
The proportion of completed sessions relative to the total prescribed sessions, expressed as a percentage.
Time frame: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.
Safety will be measured by the number of serious adverse events (SAEs)
Time frame: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.
Tolerability will be measured by the number of adverse events (AEs).
Time frame: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.
Changes in depressive symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), which ranges from 0 to 60, with higher scores indicating more severe depression. A decrease in the MADRS score will be interpreted as an improvement in symptoms.
Time frame: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.
TMS-EMG will be used to evaluate changes in SICI.
Time frame: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.
TMS-EMG will be used to evaluate changes in intracortical facilitation
Time frame: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.
TMS-EMG will be used to assess changes in the cortical silent period (CSP).
Unit of Measurement: Duration (milliseconds).
Time frame: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.
TMS-EEG will be used to evaluate changes in TMS-evoked potential (TEP) component amplitudes.
Unit of Measurement: Voltage (µV).
Time frame: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.
rsEEG will be used to analyze changes in brain activity patterns at rest.
Unit of Measurement: Frequency (Hz)
Time frame: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.
rsEEG will be used to analyze changes in brain activity patterns at rest.
Unit of Measurement: Amplitude (µV).
Contact information is provided by the study sponsor or research team.
University of California, San Diego
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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