Frontiers in human neuroscience · 2026
A prospective, open-label feasibility study protocol of home-based transcranial direct current stimulation for major depressive disorder in elective lumbar spine surgery candidates.
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Menta Arjun K, Bronckers Samuel P, Goes Fernando S, Witham Timothy F, Cohen David B, Jain Amit, Lee Sang H, Riley Lee H, Kebaish Khaled M, Lubelski Daniel, Bydon Ali, Theodore Nicholas, Azad Tej D
Аннотация
BACKGROUND: Depression is common among elective lumbar spine surgery candidates and is associated with worse postoperative outcomes. Home-based transcranial direct current stimulation (tDCS) has demonstrated safety and feasibility, with evidence of antidepressant effects in remote randomized and open-label studies of major depressive disorder (MDD). Whether this approach can be feasibly and acceptably implemented as a preoperative intervention in lumbar spine surgical populations is unknown.
METHODS: We propose a prospective, open-label, single-arm feasibility study evaluating preoperative, home-based tDCS for elective, non-revision lumbar spine surgery candidates with MDD. Adults aged 22-75 years with DSM-5 MDD and at least moderate depressive symptom severity [self-reported Montgomery-Åsberg Depression Rating Scale (MADRS-S) ≥ 20] being evaluated for elective lumbar spine surgery will receive home-based tDCS. Key exclusion criteria include history of seizure disorder, implanted cranial electronic or metallic devices, clinically unstable psychiatric conditions, prior brain stimulation therapy, and use of medications that significantly affect cortical excitability. Pre-surgical treatment follows a standardized cadence (5 sessions/week for 3 weeks, then 3 sessions/week) for a minimum of 4 weeks, continuing until surgery or up to 10 weeks. Feasibility will be assessed using a pre-specified tiered exposure framework based on the number of sessions completed before surgery.
ANTICIPATED RESULTS: Primary outcomes are feasibility and acceptability of preoperative home-based tDCS delivery. The principal exploratory clinical outcome is change in depressive symptom severity measured using MADRS-S. Exploratory perioperative recovery outcomes include spine-related disability, pain intensity, functional status, and opioid utilization. For participants who proceed to surgery, postoperative outcomes will be followed up to 12 months.
DISCUSSION: This pilot study will generate feasibility, acceptability, and preliminary signal data to inform the design of future randomized controlled trials of preoperative neuromodulation in surgical populations.
METHODS: We propose a prospective, open-label, single-arm feasibility study evaluating preoperative, home-based tDCS for elective, non-revision lumbar spine surgery candidates with MDD. Adults aged 22-75 years with DSM-5 MDD and at least moderate depressive symptom severity [self-reported Montgomery-Åsberg Depression Rating Scale (MADRS-S) ≥ 20] being evaluated for elective lumbar spine surgery will receive home-based tDCS. Key exclusion criteria include history of seizure disorder, implanted cranial electronic or metallic devices, clinically unstable psychiatric conditions, prior brain stimulation therapy, and use of medications that significantly affect cortical excitability. Pre-surgical treatment follows a standardized cadence (5 sessions/week for 3 weeks, then 3 sessions/week) for a minimum of 4 weeks, continuing until surgery or up to 10 weeks. Feasibility will be assessed using a pre-specified tiered exposure framework based on the number of sessions completed before surgery.
ANTICIPATED RESULTS: Primary outcomes are feasibility and acceptability of preoperative home-based tDCS delivery. The principal exploratory clinical outcome is change in depressive symptom severity measured using MADRS-S. Exploratory perioperative recovery outcomes include spine-related disability, pain intensity, functional status, and opioid utilization. For participants who proceed to surgery, postoperative outcomes will be followed up to 12 months.
DISCUSSION: This pilot study will generate feasibility, acceptability, and preliminary signal data to inform the design of future randomized controlled trials of preoperative neuromodulation in surgical populations.