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| ID | Type | Description | Link |
|---|---|---|---|
| 812687 | Registry Identifier | Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spaced Transcranial Direct Current Stimulation Treatment | Experimental | tDCS, a non-invasive neuromodulation technique that applies low-intensity, direct electrical stimulation to the cortex via scalp electrodes, has been extensively researched as a potential treatment for MDD. tDCS enhances neuroplasticity, which is theorized to be responsible for its therapeutic effects and has been presented as a cost-effective solution for MDD. Preclinical evidence supports the potential advantage of spaced stimulation with tDCS to maximally engage neuroplasticity. tDCS sessions will be self-administered at home under the supervision of a trained clinical research coordinator. Each treatment day will consist of five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours per day. Other Names:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spaced Transcranial Direct Current Stimulation (tDCS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (Recruitment) | Recruitment rate will be measured as the number of patients enrolled by the conclusion of the study, reported as a whole number. | From baseline clinical assessment prior to treatment to 12 weeks after last treatment. |
| Feasibility (Retention) | Retention rate will be measured as the percentage of enrolled patients who complete all study visits, reported as a percentage. | From baseline clinical assessment prior to treatment, to 12 weeks after last treatment. |
| Feasibility (Adherence) | The proportion of completed sessions relative to the total prescribed sessions, expressed as a percentage. | From baseline clinical assessment prior to treatment, to 12 weeks after last treatment. |
| Safety of at-home spaced tDCS | Safety will be measured by the number of serious adverse events (SAEs) | From baseline clinical assessment prior to treatment, to 12 weeks after last treatment. |
| Tolerability to spaced tDCS | Tolerability will be measured by the number of adverse events (AEs). | From baseline clinical assessment prior to treatment, to 12 weeks after last treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from pre-treatment depressive symptomatology in post-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. | From baseline clinical assessment prior to treatment, to 12 weeks after last treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Interventional Psychiatry | Contact | 858-966-5832 | iptrials@health.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Interventional Psychiatry | Recruiting | San Diego | California | 92127 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29877965 | Background | Stagg CJ, Antal A, Nitsche MA. Physiology of Transcranial Direct Current Stimulation. J ECT. 2018 Sep;34(3):144-152. doi: 10.1097/YCT.0000000000000510. | |
| 29415152 | Background | Williams NR, Sudheimer KD, Bentzley BS, Pannu J, Stimpson KH, Duvio D, Cherian K, Hawkins J, Scherrer KH, Vyssoki B, DeSouza D, Raj KS, Keller J, Schatzberg AF. High-dose spaced theta-burst TMS as a rapid-acting antidepressant in highly refractory depression. Brain. 2018 Mar 1;141(3):e18. doi: 10.1093/brain/awx379. No abstract available. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 2, 2025 | Aug 28, 2025 |
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| Biomarker Discovery: Short-Interval Intracortical Inhibition (SICI) via TMS-EMG | TMS-EMG will be used to evaluate changes in SICI. | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. |
| Biomarker Discovery: Intracortical Facilitation (ICF) via TMS-EMG | TMS-EMG will be used to evaluate changes in intracortical facilitation | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. |
| Biomarker Discovery: Cortical Silent Period (CSP) via Transcranial Magnetic Stimulation-Electromyography (TMS-EMG) | TMS-EMG will be used to assess changes in the cortical silent period (CSP). Unit of Measurement: Duration (milliseconds). | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. |
| Biomarker Discovery: TMS-Evoked Potential (TEP) Component Amplitudes via TMS-EEG | TMS-EEG will be used to evaluate changes in TMS-evoked potential (TEP) component amplitudes. Unit of Measurement: Voltage (µV). | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. |
| Biomarker Discovery: Resting-State Electroencephalography (rsEEG) | rsEEG will be used to analyze changes in brain activity patterns at rest. Unit of Measurement: Frequency (Hz) | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. |
| Biomarker Discovery: Resting-State Electroencephalography (rsEEG) | rsEEG will be used to analyze changes in brain activity patterns at rest. Unit of Measurement: Amplitude (µV). | From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment. |
| 23389323 | Background | Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013 Apr;70(4):383-91. doi: 10.1001/2013.jamapsychiatry.32. |
| 28657871 | Background | Brunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, Veronezi BP, Nogueira BS, Aparicio LVM, Razza LB, Chamorro R, Tort LC, Fraguas R, Lotufo PA, Gattaz WF, Fregni F, Bensenor IM; ELECT-TDCS Investigators. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999. |
| 20434997 | Background | Fritsch B, Reis J, Martinowich K, Schambra HM, Ji Y, Cohen LG, Lu B. Direct current stimulation promotes BDNF-dependent synaptic plasticity: potential implications for motor learning. Neuron. 2010 Apr 29;66(2):198-204. doi: 10.1016/j.neuron.2010.03.035. |
| 36801903 | Background | Jog MA, Anderson C, Kubicki A, Boucher M, Leaver A, Hellemann G, Iacoboni M, Woods R, Narr K. Transcranial direct current stimulation (tDCS) in depression induces structural plasticity. Sci Rep. 2023 Feb 17;13(1):2841. doi: 10.1038/s41598-023-29792-6. |
| 10990547 | Background | Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x. |
| 35839661 | Background | Woodham RD, Rimmer RM, Young AH, Fu CHY. Adjunctive home-based transcranial direct current stimulation treatment for major depression with real-time remote supervision: An open-label, single-arm feasibility study with long term outcomes. J Psychiatr Res. 2022 Sep;153:197-205. doi: 10.1016/j.jpsychires.2022.07.026. Epub 2022 Jul 8. |
| 39433921 | Background | Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Rizvi M, Kwon SS, Orhii P, Maislin D, Hernandez L, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med. 2025 Jan;31(1):87-95. doi: 10.1038/s41591-024-03305-y. Epub 2024 Oct 21. |
| 29213226 | Background | Thair H, Holloway AL, Newport R, Smith AD. Transcranial Direct Current Stimulation (tDCS): A Beginner's Guide for Design and Implementation. Front Neurosci. 2017 Nov 22;11:641. doi: 10.3389/fnins.2017.00641. eCollection 2017. |
| 39327744 | Background | Vogelmann U, Pilloni G, Brunoni AR, Charvet L. How can we develop transcranial direct current stimulation into an effective at-home treatment tool for depression? Expert Rev Med Devices. 2024 Oct;21(10):883-886. doi: 10.1080/17434440.2024.2409767. Epub 2024 Sep 26. No abstract available. |
| 39876681 | Background | Couture M, Desbeaumes Jodoin V, Bousseau E, Sarshoghi A, Nitsche MA, Blumberger DM, Bolduc C, Weissman CR, Appelbaum LG, Daskalakis ZJ, Poorganji M, Lesperance P, Miron JP. Spaced Transcranial Direct Current Stimulation for Major Depression. Am J Psychiatry. 2025 Mar 1;182(3):276-284. doi: 10.1176/appi.ajp.20240083. Epub 2025 Jan 29. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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