Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study

Обзор

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.

Вмешательства

• Устройство Spaced Transcranial Direct Current Stimulation (tDCS)
  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.

Первичные конечные точки

• Feasibility (Recruitment) [Срок оценки: From baseline clinical assessment prior to treatment to 12 weeks after last treatment.]
• Feasibility (Retention) [Срок оценки: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.]
• Feasibility (Adherence) [Срок оценки: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.]
• Safety of at-home spaced tDCS [Срок оценки: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.]
• Tolerability to spaced tDCS [Срок оценки: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.]

Вторичные конечные точки (7)

• Changes from pre-treatment depressive symptomatology in post-treatment [Срок оценки: From baseline clinical assessment prior to treatment, to 12 weeks after last treatment.]
• Biomarker Discovery: Short-Interval Intracortical Inhibition (SICI) via TMS-EMG [Срок оценки: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.]
• Biomarker Discovery: Intracortical Facilitation (ICF) via TMS-EMG [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.]
• Biomarker Discovery: Resting-State Electroencephalography (rsEEG) [Срок оценки: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.]
• Biomarker Discovery: Resting-State Electroencephalography (rsEEG) [Срок оценки: From baseline neurophysiological assessment prior to treatment, to during treatment, to 12 weeks after last treatment.]

Критерии участия

Критерии включения

• People between the ages of 18 and 85 at the time of screening.
• Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20.
• Safe for TMS as measures by the TMS Adult Safety Screening (TASS).
• Medical records confirming a history of failing to achieve clinical response to an adequate antidepressant trial as defined an Antidepressant Treatment History Form (ATHF) score ≥ 3 or ) or shown intolerance to at least two inadequate trials (score 1 or 2), without psychiatric illness due to a general medical condition.
• Stable internet connection and a device compatible with Microsoft Teams.

Критерии исключения

• History of psychotic or bipolar disorder or depression with psychotic features;
• Significant borderline personality disorder;
• Significant comorbid obsessive-compulsive or post-traumatic stress:
• Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
• Clinically significant suicidality disorder;
• Chronic depression (defined as of over 5 years duration);
• Pregnancy or lactation, lack of adequate birth control in women of childbearing age;
• History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent symptoms;
• Unstable medical illness;
• Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion);
• History of TMS (greater than 15 sessions) without a clinically meaningful response.; History of ketamine (greater than 4 sessions) without a clinically meaningful response;
• Require a benzodiazepine with a dose > lorazepam 2 mg/day;
• dermatological conditions contraindicating tDCS;
• Non-correctable sensory impairments;
• Inability to consent or participate as an outpatient

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• UCSD Interventional Psychiatry — San Diego

Публикации

• 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. PMID 29877965
• 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. PMID 29415152
• 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. PMID 23389323
• 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. PMID 28657871
• 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. PMID 20434997
• 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. PMID 36801903
• 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. PMID 10990547
• 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. PMID 35839661

Идентификаторы

NCT: NCT07217223 · 812687 · 812687

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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