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Safety and Feasibility of Tele-Supervised Home-Based Transcranial Direct Current Stimulation for Major Depressive Disorder.

ABSTRACT: Major depressive disorder (MDD) is a worldwide cause of disability in older age, especially during the covid pandemic. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that has shown encouraging efficacy for treatment of depression. Here, we investigate the feasibility of an innovative protocol where tDCS is administered within the homes of older adults with MDD (patient participants) with the help of a study companion (i.e. caregiver). We further analyze the feasibility of a remotely-hosted training program that provides the knowledge and skills to administer tDCS at home, without requiring them to visit the lab. We also employed a newly developed multi-channel tDCS system with real-time monitoring designed to guarantee the safety and efficacy of home-based tDCS. Patient participants underwent a total of 37 home-based tDCS sessions distributed over 12 weeks. The protocol consisted of three phases each lasting four weeks: an acute phase, containing 28 home-based tDCS sessions, a taper phase containing nine home-based tDCS sessions, and a follow up phase, with no stimulation sessions. We found that the home-based, remotely-supervised, study companion administered, multi-channel tDCS protocol for older adults with MDD was feasible and safe. Further, the study introduces a novel training program for remote instruction of study companions in the administration of tDCS. Future research is required to determine the translatability of these findings to a larger sample. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04799405?term=NCT04799405&draw=2&rank=1, identifier NCT04799405.

SUBMITTER: Cappon D

PROVIDER: S-EPMC8849231 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Safety and Feasibility of Tele-Supervised Home-Based Transcranial Direct Current Stimulation for Major Depressive Disorder.

Cappon Davide D den Boer Tim T Jordan Caleb C Yu Wanting W Lo Alexander A LaGanke Nicole N Biagi Maria Chiara MC Skorupinski Pawel P Ruffini Giulio G Morales Oscar O Metzger Eran E Manor Bradley B Pascual-Leone Alvaro A

Frontiers in aging neuroscience 20220202

Major depressive disorder (MDD) is a worldwide cause of disability in older age, especially during the covid pandemic. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that has shown encouraging efficacy for treatment of depression. Here, we investigate the feasibility of an innovative protocol where tDCS is administered within the homes of older adults with MDD (patient participants) with the help of a study companion (i.e. caregiver). We further analyz ...[more]

PMID: 35185515

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Project description:BackgroundOver 55 million people worldwide are currently diagnosed with Alzheimer's disease (AD) and live with debilitating episodic memory deficits. Current pharmacological treatments have limited efficacy. Recently, transcranial alternating current stimulation (tACS) has shown memory improvement in AD by normalizing high-frequency neuronal activity. Here we investigate the feasibility, safety, and preliminary effects on episodic memory of an innovative protocol where tACS is administered within the homes of older adults with AD with the help of a study companion (HB-tACS).MethodsEight participants diagnosed with AD underwent multiple consecutive sessions of high-definition HB-tACS (40 Hz, 20-min) targeting the left angular gyrus (AG), a key node of the memory network. The Acute Phase comprised 14-weeks of HB-tACS with at least five sessions per week. Three participants underwent resting state electroencephalography (EEG) before and after the 14-week Acute Phase. Subsequently, participants completed a 2-3-month Hiatus Phase not receiving HB-tACS. Finally, in the Taper phase, participants received 2-3 sessions per week over 3-months. Primary outcomes were safety, as determined by the reporting of side effects and adverse events, and feasibility, as determined by adherence and compliance with the study protocol. Primary clinical outcomes were memory and global cognition, measured with the Memory Index Score (MIS) and Montreal Cognitive Assessment (MoCA), respectively. Secondary outcome was EEG theta/gamma ratio. Results reported as mean ± SD.ResultsAll participants completed the study, with an average of 97 HB-tACS sessions completed by each participant; reporting mild side effects during 25% of sessions, moderate during 5%, and severe during 1%. Acute Phase adherence was 98 ± 6.8% and Taper phase was 125 ± 22.3% (rates over 100% indicates participants completed more than the minimum of 2/week). After the Acute Phase, all participants showed memory improvement, MIS of 7.25 ± 3.77, sustained during Hiatus 7.00 ± 4.90 and Taper 4.63 ± 2.39 Phases compared to baseline. For the three participants that underwent EEG, a decreased theta/gamma ratio in AG was observed. Conversely, participants did not show improvement in the MoCA, 1.13 ± 3.80 after the Acute Phase, and there was a modest decrease during the Hiatus -0.64 ± 3.28 and Taper -2.56 ± 5.03 Phases.ConclusionThis pilot study shows that the home-based, remotely-supervised, study companion administered, multi-channel tACS protocol for older adults with AD was feasible and safe. Further, targeting the left AG, memory in this sample was improved. These are preliminary results that warrant larger more definite trials to further elucidate tolerability and efficacy of the HB-tACS intervention. NCT04783350.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04783350?term=NCT04783350&draw=2&rank=1, identifier NCT04783350.

Project description:ImportanceTranscranial direct current stimulation (tDCS) is moderately effective for depression when applied by trained staff. It is not known whether self-applied tDCS, combined or not with a digital psychological intervention, is also effective.ObjectiveTo determine whether fully unsupervised home-use tDCS, combined with a digital psychological intervention or digital placebo, is effective for a major depressive episode.Design, setting, and participantsThis was a double-blinded, sham-controlled, randomized clinical trial with 3 arms: (1) home-use tDCS plus a digital psychological intervention (double active); (2) home-use tDCS plus digital placebo (tDCS only), and (3) sham home-use tDCS plus digital placebo (double sham). The study was conducted between April 2021 and October 2022 at participants' homes and at Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil. Included participants were aged 18 to 59 years with major depression and a Hamilton Depression Rating Scale, 17-item version (HDRS-17), score above 16, a minimum of 8 years of education, and access to a smartphone and internet at home. Exclusion criteria were other psychiatric disorders, except for anxiety; neurologic or clinical disorders; and tDCS contraindications.InterventionstDCS was administered in 2-mA, 30-minute prefrontal sessions for 15 consecutive weekdays (1-mA, 90-second duration for sham) and twice-weekly sessions for 3 weeks. The digital intervention consisted of 46 sessions based on behavioral therapy. Digital placebo was internet browsing.Main outcomes and measuresChange in HDRS-17 score at week 6.ResultsOf 837 volunteers screened, 210 participants were enrolled (180 [86%] female; mean [SD] age, 38.9 [9.3] years) and allocated to double active (n = 64), tDCS only (n = 73), or double sham (n = 73). Of the 210 participants enrolled, 199 finished the trial. Linear mixed-effects models did not reveal statistically significant group differences in treatment by time interactions for HDRS-17 scores, and the estimated effect sizes between groups were as follows: double active vs tDCS only (Cohen d, 0.05; 95% CI, -0.48 to 0.58; P = .86), double active vs double sham (Cohen d, -0.20; 95% CI, -0.73 to 0.34; P = .47), and tDCS only vs double sham (Cohen d, -0.25; 95% CI, -0.76 to 0.27; P = .35). Skin redness and heat or burning sensations were more frequent in the double active and tDCS only groups. One nonfatal suicide attempt occurred in the tDCS only group.Conclusions and relevanceUnsupervised home-use tDCS combined with a digital psychological intervention or digital placebo was not found to be superior to sham for treatment of a major depressive episode in this trial.Trial registrationClinicalTrials.gov Identifier: NCT04889976.

Project description:BackgroundTranscranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has been shown to improve common symptoms of neurological disorders like depressed mood, fatigue, motor deficits and cognitive dysfunction. tDCS requires daily treatment sessions in order to be effective. We developed a remotely supervised tDCS (RS-tDCS) protocol for participants with multiple sclerosis (MS) to increase accessibility of tDCS, reducing clinician, patient, and caregiver burden. The goal of this protocol is to facilitate home use for larger trials with extended treatment periods. In this study we determine the generalizability of RS-tDCS paired with cognitive training (CT) by testing its feasibility in participants with Parkinson's disease (PD).MethodsFollowing the methods in our MS protocol development, we enrolled sixteen participants (n = 12 male, n = 4 female; mean age 66 years) with PD to complete ten open-label sessions of RS-tDCS paired with CT (2.0 mA × 20 min) at home under the remote supervision of a trained study technician. Tolerability data were collected before, during, and after each individual session. Baseline and follow-up measures included symptom inventories (fatigue and sleep) and cognitive assessments.ResultsRS-tDCS was feasible and tolerable for patients with PD, with at-home access leading to high protocol compliance. Side effects were mostly limited to mild sensations of transient itching and burning under the electrode sites. Similar to prior finding sin MS, we found preliminary efficacy for improvement of fatigue and cognitive processing speed in PD.ConclusionsRS-tDCS paired with CT is feasible for participants with PD to receive at home treatment. Signals of benefit for reduced fatigue and improved cognitive processing speed are consistent across the PD and MS samples. RS-tDCS can be generalized to provide tDCS to a range of patients with neurologic disorders for at-home rehabilitation.Trial registrationClinicalTrials.gov Identifier: NCT02746705 . Registered April 21st 2016.

Project description:Objective: Chronic pain in knee osteoarthritis (OA) is a multidimensional phenomenon requiring thorough assessment and appropriate treatment. We assessed the impact of home-based, remotely supervised transcranial direct current stimulation (tDCS) on the overall pain experience of older adults with knee OA by simultaneously examining its effects on multiple pain domains-pain intensity, pain interference, and pain catastrophizing-using multigroup latent transition analysis (LTA). Methods: This secondary analysis of a randomized clinical trial involved 120 participants with knee OA pain, randomly assigned in a 1:1 ratio to receive 15 daily sessions of 2-mA tDCS or sham tDCS (20 min per session) over three weeks, with real-time remote supervision. Pain intensity was measured using the Numeric Rating Scale (NRS) and the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index. Pain interference was measured using the WOMAC functional scale. Pain catastrophizing was assessed using the Pain Catastrophizing Scale (PCS). All the measures were assessed at baseline and at the end of each week (weeks 1, 2, and 3), after the participants had completed five tDCS sessions per week. Multigroup LTA enabled the simultaneous measurement of multiple pain domains and analysis of their changes as a function of intervention exposure by modeling the transition probabilities of latent classes and comparing these changes between the groups. Results: Based on the NRS, WOMAC, and PCS scores, three latent categories were identified: "high pain (all scores high)," "moderate pain (all scores moderate)," and "low pain (all scores low)." Active group participants with "moderate pain" at baseline had a 24.2% probability of transitioning to "low pain" after Week 1, whereas sham group participants remained stagnant during this interval. Notably, 37.6% of active group participants with "high pain" at Week 1 transitioned to "moderate pain," while 35.8% of those with "moderate pain" at Week 1 transitioned to "low pain" by Week 2 (after an additional five sessions). Nevertheless, no noticeable changes were observed in the sham group during this period. No pronounced intervention effects were noted by Week 3. Conclusions: Simultaneously modeling pain-related measures enriches our understanding of the efficacy of tDCS in improving the overall pain experience among older adults with knee OA. Trial Registration: ClinicalTrials.gov identifier: NCT04016272.

Project description:PurposeProof-of-principle human studies suggest that transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (L-DLPFC) may improve the clinical symptoms of depression. This multicenter study (N=35) tested remotely supervised and repeated daily multichannel tDCS delivered at home designed to target the L-DLPFC in a group of patients with major depressive disorder (MDD). The main objectives of the study were to assess the feasibility and safety of home-based, remotely-supervised tDCS for patients with MDD. As an exploratory aim, we also aimed to evaluate the efficacy. The primary efficacy measure for this study was the median percent change from baseline to the end of the 4-week post-treatment follow-up period in the observer-rated Montgomery-Asberg Depression Mood Rating Scale (MADRS).MethodsFor each study participant, this open-label feasibility telemedicine pilot study involved 37 at-home stimulation sessions (30 minutes each) of multichannel tDCS targeting L-DLPFC administered over eight weeks, with a follow-up period of 4 weeks following the final stimulation session. The stimulation montage (electrode positions and currents) was optimized by employing computational models using available structural data from a similar population (group optimization). Conducted entirely remotely, the study employed the MADRS for assessment at baseline, at weeks 4 and 8 during treatment, and at 4-week follow-up visits.ResultsThe population who completed all study visits consisted of 34 patients (85.3% women and 14.7% men) with a mean age of 59 years, a diagnosis of MDD according to DSM-V criteria, and a MADRS score ≥20 at the time of study enrolment. At baseline, the mean time since MDD diagnosis was 24.0 (SD 19.1) months. Nearly 90% of the participants (n=29) completed the full course of 37 stimulation sessions at home, covering both the acute and taper phases. No detrimental effects were observed, and no participants had suicidal ideation and/or behavior, whether at baseline during treatment or during the four weeks post-treatment. The study observed a Median percentage MADRS score reduction of 64.5% (48.6, 72.4). Over 70% of participants (n=24) showed a ≥ 50% improvement in MADRS scores from baseline to the last visit (4 weeks post-treatment), with a response rate (RR) of 72.7%. Secondary measures, including the Quick Inventory of Depressive Symptomatology-Self Report (QUIDS-SR) and the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF), reflected similar improvements. The mean (SD) and the median difference between the final visit and baseline for the Q-LES-Q-SF score were 27.9 (13.8) and 26.8 (17.9, 35.7), respectively.ConclusionsThese results suggest that remotely supervised and supported home-based tDCS is safe and feasible, and antidepressant efficacy motivates further appropriately controlled clinical studies.

Project description:IntroductionMagnetoencephalography (MEG) can measure weak magnetic fields produced by electrical brain activity. Transcranial direct current stimulation (tDCS) can affect such brain activities. The concurrent application of both, however, is challenging because tDCS presents artifacts on the MEG signal. If brain activity during tDCS can be elucidated by MEG, mechanisms of plasticity-inducing and other effects of tDCS would be more comprehensively understood. We tested the technical feasibility of MEG during tDCS using a phantom that produces an artificial current dipole simulating focal brain activity. An earlier study investigated estimation of a single oscillating phantom dipole during tDCS, and we systematically tested multiple dipole locations with a different MEG device.MethodsA phantom provided by the manufacturer was used to produce current dipoles from 32 locations. For the 32 dipoles, MEG was recorded with and without tDCS. Temporally extended signal space separation (tSSS) was applied for artifact rejection. Current dipole sources were estimated as equivalent current dipoles (ECDs). The ECD modeling quality was assessed using localization error, amplitude error, and goodness of fit (GOF). The ECD modeling performance with and without tDCS, and with and without tSSS was assessed.ResultsMean localization errors of the 32 dipoles were 1.70 ± 0.72 mm (tDCS off, tSSS off, mean ± standard deviation), 6.13 ± 3.32 mm (tDCS on, tSSS off), 1.78 ± 0.83 mm (tDCS off, tSSS on), and 5.73 ± 1.60 mm (tDCS on, tSSS on). Mean GOF findings were, respectively, 92.3, 87.4, 97.5, and 96.7%. Modeling was affected by tDCS and restored by tSSS, but improvement of the localization error was marginal, even with tSSS. Also, the quality was dependent on the dipole location.DiscussionConcurrent tDCS-MEG recording is feasible, especially when tSSS is applied for artifact rejection and when the assumed location of the source of activity is favorable for modeling. More technical studies must be conducted to confirm its feasibility with different source modeling methods and stimulation protocols. Recovery of single-trial activity under tDCS warrants further research.

Dataset Information

Safety and Feasibility of Tele-Supervised Home-Based Transcranial Direct Current Stimulation for Major Depressive Disorder.

Publications

Safety and Feasibility of Tele-Supervised Home-Based Transcranial Direct Current Stimulation for Major Depressive Disorder.

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