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Heart Rate Variability (HRV) serves as an objective correlate of distress and symptom burden in multiple sclerosis
Pilloni, Giuseppina; Best, Pamela; Kister, Ilya; Charvet, Leigh
BACKGROUND/UNASSIGNED:Autonomic nervous system (ANS) dysfunction is frequently seen in people living with multiple sclerosis (MS). Heart rate variability (HRV) is an easy and objective index for evaluating ANS functioning, and it has been previously used to explore the association between ANS and the experience of symptom burden in other chronic diseases. Given ANS functioning can be influenced by physical and psychological factors, this study investigated whether emotional distress and/or the presence of ANS dysfunction is associated with symptom severity in people living with MS. METHODS/UNASSIGNED:Participants with MS and healthy controls (HC) with no history of cardiac conditions were recruited to self-collect HR data sampled from a chest strap HR monitor (PolarH10). Short-term HR signal was collected for five minutes, and time and frequency HRV analyses were performed and compared between groups. HRV values were then compared to self-reported distress (Kessler Psychological Distress Scale) and MS participants' self-reported measures of symptom burden (SymptoMScreen). RESULTS/UNASSIGNED:= 0.007). A significant mediation effect was also observed, with emotional distress fully mediating the association between HRV and symptom burden. CONCLUSIONS/UNASSIGNED:These findings suggest the potential for ANS dysfunction, as measured by HRV (i.e., lower value of HF power), to be utilized as an objective marker of symptom burden in people living with MS. Moreover, it is apparent that the relationship between HRV and symptom burden is mediated by emotional distress.
PMCID:10958478
PMID: 38525015
ISSN: 2174-0852
CID: 5644422
Immediate and Differential Response to Emotional Stimuli Associated With Transcranial Direct Current Stimulation for Depression: A Visual-Search Task Pilot Study
Pilloni, Giuseppina; Cho, Hyein; Tian, Tian Esme; Beringer, Joerg; Bikson, Marom; Charvet, Leigh
OBJECTIVES/OBJECTIVE:When administered in repeated daily doses, transcranial direct current stimulation (tDCS) directed to the prefrontal cortex has cumulative efficacy for the treatment of depression. Depression can be marked by altered processing of emotionally salient information. An acute marker of response to tDCS may be measured as an immediate change in emotional information processing. Using an easily administered web-based task, we tested immediate changes in emotional information processing in acute response to tDCS in participants with and without depression. MATERIALS AND METHODS/METHODS:We enrolled n = 21 women with mild-to-moderate depression and n = 20 controls without depression to complete a web-based visual search task before and after 30 minutes of tDCS directed to the prefrontal cortex. The timed task required participants to identify a target face among arrays showing sad, neutral, or mixed (distractor) expressions. RESULTS:At baseline, as predicted, the participants with depression differed from those without in emotional processing speed (mean z score difference -0.66 ± 0.27, p = 0.022) and accuracy in identifying sad stimuli (error rate: 4.4% vs 1.8%, p = 0.039). In response to tDCS, the participants with depression became significantly faster on the distractor condition (pre- vs post-tDCS z scores: -0.45 ± 0.65 vs -0.85 ± 0.65, p = 0.009), suggesting a specific reduction in bias toward negative emotional information. In response to tDCS, the depressed group also had significant improvements in self-reported mood (increased happy, decreased sad and anxious mood). CONCLUSIONS:Participants with depression vs those without were differentiated by their performance of the visual search task at baseline and in response to tDCS. Given that measurable effects on depression scales may require weeks of tDCS treatments, acute change in emotional information processing can serve as an easily obtainable marker of depression and its response to tDCS. CLINICAL TRIAL REGISTRATION/BACKGROUND:The Clinicaltrials.gov registration number for the study is NCT05188248.
PMID: 37598327
ISSN: 1525-1403
CID: 5598122
Moving intra-individual variability (IIV) towards clinical utility: IIV measured using a commercial testing platform
Cho, Hyein; Pilloni, Giuseppina; Tahsin, Raisa; Best, Pamela; Krupp, Lauren; Oh, Cheongeun; Charvet, Leigh
OBJECTIVES:Intra-individual variability (IIV), measured across repeated response times (RT) during continuous psychomotor tasks, is an early marker of cognitive change in the context of neurodegeneration. To advance IIV towards broader application in clinical research, we evaluated IIV from a commercial cognitive testing platform and compared it to the calculation approaches used in experimental cognitive studies. METHODS:-transformed standard deviation or "LSD"). We calculated IIV from the raw RTs using coefficient of variation (CoV), regression-based, and ex-Gaussian methods. The IIV from each calculation was then compared by rank across participants. RESULTS:A total of n = 120 participants with MS aged 20-72 (Mean ± SD, 48.99 ± 12.09) completed the baseline cognitive measures. For each task, the interclass correlation coefficient was generated. Each ICC showed that LSD, CoV, ex-Gaussian, and regression methods clustered strongly (Average ICC for DET: 0.95 with 95% CI [0.93, 0.96]; Average ICC for IDN: 0.92 with 95% CI [0.88 to 0.93]; Average ICC for ONB: 0.93 with 95% CI [0.90 to 0.94]). Correlational analyses indicated the strongest correlation between LSD and CoV for all tasks (rs ≥ 0.94). CONCLUSION:The LSD was consistent with research-based methods for IIV calculations. These findings support the use of LSD for the future measurement of IIV for clinical studies.
PMID: 36812823
ISSN: 1878-5883
CID: 5430202
Home-administered transcranial direct current stimulation is a feasible intervention for depression: an observational cohort study
Charvet, Leigh; George, Allan; Charlson, Erik; Lustberg, Matthew; Vogel-Eyny, Amy; Eilam-Stock, Tehila; Cho, Hyein; Best, Pamela; Fernandez, Luis; Datta, Abhishek; Bikson, Marom; Nazim, Kamran; Pilloni, Giuseppina
Transcranial direct current stimulation (tDCS) is an emerging treatment for major depression. We recruited participants with moderate-to-severe major depressive episodes for an observational clinical trial using Soterix Medical's tDCS telehealth platform as a standard of care. The acute intervention consisted of 28 sessions (5 sessions/week, 6 weeks) of the left anodal dorsolateral prefrontal cortex (DLPFC) tDCS (2.0 mA × 30 min) followed by a tapering phase of weekly sessions for 4 weeks (weeks 7-10). The n = 16 completing participants had a significant reduction in depressive symptoms by week 2 of treatment [Montgomery-Åsberg Depression Rating Scale (MADRS), Baseline: 28.00 ± 4.35 vs. Week 2: 17.12 ± 5.32, p < 0.001] with continual improvement across each biweekly timepoint. Acute intervention responder and remission rates were 75 and 63% and 88 and 81% following the taper period (week 10).
PMCID:10477781
PMID: 37674552
ISSN: 1664-0640
CID: 5602552
Tolerability and feasibility of at-home remotely supervised transcranial direct current stimulation (RS-tDCS): Single-center evidence from 6,779 sessions
Pilloni, Giuseppina; Vogel-Eyny, Amy; Lustberg, Matthew; Best, Pamela; Malik, Martin; Walton-Masters, Lillian; George, Allan; Mirza, Ibraheem; Zhovtis, Lana; Datta, Abhishek; Bikson, Marom; Krupp, Lauren; Charvet, Leigh
INTRODUCTION/BACKGROUND:The ability to deploy transcranial direct current stimulation (tDCS) at home is a key usability advantage to support scaling for pivotal clinical trials. We have established a home-based tDCS protocol for use in clinical trials termed remotely supervised (RS)-tDCS. OBJECTIVE:To report the tolerability and feasibility of tDCS sessions completed to date using RS-tDCS in clinical trials. METHODS:We analyzed tolerability (i.e., adverse events, AEs) reported in six Class I/II/III trials using RS-tDCS to study symptom outcomes over 10 to 60 daily applications. Across the six clinical trials, 308 participants (18-78 years old) completed an average of 23 sessions for a total of 6779 RS-tDCS administrations. The majority of participants were diagnosed with multiple sclerosis, and open-label trials included those diagnosed with a range of other conditions (e.g., Parkinson's disease, post-stroke aphasia, traumatic brain injury, cerebellar ataxia), with minimum-to-severe neurologic disability. Clinical trial feasibility (i.e., treatment fidelity and blinding integrity) was examined using two Class I randomized controlled trials (RCTs). RESULTS:No serious AEs occurred. Across administrations, three sessions (0.04%) were aborted due to discomfort, but no participant discontinued due to tolerability. The AEs most commonly reported by participants were tingling (68%), itching (41%) and warmth sensation (42%) at the electrode site, and these were equally reported in active and sham tDCS conditions. The two Class I RCTs resulted in rapid enrollment, high fidelity to treatment completion, and blinding integrity. CONCLUSIONS:At-home RS-tDCS is tolerable, including when used over extended periods of time. Home-based RS-tDCS is feasible and can enable Class I tDCS clinical trial designs.
PMID: 35470019
ISSN: 1876-4754
CID: 5217352
Home-based transcranial direct current stimulation paired with cognitive training to reduce fatigue in multiple sclerosis
Charvet, Leigh; Goldberg, Judith D; Li, Xiaochun; Best, Pamela; Lustberg, Matthew; Shaw, Michael; Zhovtis, Lana; Gutman, Josef; Datta, Abhishek; Bikson, Marom; Pilloni, Giuseppina; Krupp, Lauren
Fatigue is a common and often debilitating feature of multiple sclerosis (MS) that lacks reliably effective treatment options for most patients. Transcranial direct current stimulation (tDCS), a safe and well-tolerated type of noninvasive brain stimulation, is a low-cost and home-based approach with the potential to reduce fatigue in MS. We conducted a double-blind, sham-controlled, randomized clinical trial to compare active vs. low-dose (sham) tDCS paired with computer-based cognitive training, delivered as a home-based intervention, to reduce MS-related fatigue. Participants with MS-related fatigue, but without depression, were stratified by neurologic disability using the Extended Disability Status Scale (EDSS) and randomized to complete 30 daily sessions over six weeks of either active or sham tDCS paired with online cognitive training (BrainHQ). The primary outcome was the change in PROMIS Fatigue score from baseline to the end of the intervention. A total of 117 participants were randomized, with 92% completing all treatment sessions. Both groups showed significant reductions in fatigue, with no significant difference between them. This suggests that tDCS does not provide any additional benefit over cognitive training alone in reducing fatigue, but confirms the feasibility and tolerance of this home-based intervention.
PMCID:11802740
PMID: 39915560
ISSN: 2045-2322
CID: 5784342
How can we develop transcranial direct current stimulation into an effective at-home treatment tool for depression? [Editorial]
Vogelmann, Ulrike; Pilloni, Giuseppina; Brunoni, Andre R; Charvet, Leigh
PMID: 39327744
ISSN: 1745-2422
CID: 5711492
Hand functioning in progressive multiple sclerosis improves with tDCS added to daily exercises: A home-based randomized, double-blinded, sham-controlled clinical trial
Pilloni, Giuseppina; Lustberg, Matthew; Malik, Martin; Feinberg, Charles; Datta, Abhishek; Bikson, Marom; Gutman, Josef; Krupp, Lauren; Charvet, Leigh
BACKGROUND/UNASSIGNED:Many individuals with progressive multiple sclerosis (PMS) are challenged by reduced manual dexterity and limited rehabilitation options. Transcranial direct current stimulation (tDCS) during motor training can improve rehabilitation outcomes. We developed a protocol for remotely supervising tDCS to deliver sessions of stimulation paired with training at home. OBJECTIVE/UNASSIGNED:This study evaluated the effectiveness of at-home tDCS paired with manual dexterity training for individuals with PMS. METHODS/UNASSIGNED:Sixty-five right-hand dominant participants with PMS and hand impairment were randomized to receive either active or sham M1-SO tDCS paired with manual dexterity training over 4 weeks. Clinical outcomes were measured by the changes in Nine-Hole Peg Test (9-HPT) and Dellon-Modified-Moberg-Pick-Up Test (DMMPUT). RESULTS/UNASSIGNED:= 0.04). CONCLUSION/UNASSIGNED:At-home tDCS paired with manual dexterity training is effective for individuals with PMS, with M1-SO tDCS enhancing training outcomes and offering a promising intervention for improving and preserving hand dexterity.
PMID: 39268655
ISSN: 1477-0970
CID: 5719392
Hand functioning in progressive multiple sclerosis improves with tDCS added to daily exercises: A home-based randomized, double-blinded, sham-controlled clinical trial
Pilloni, Giuseppina; Lustberg, Matthew; Malik, Martin; Feinberg, Charles; Datta, Abhishek; Bikson, Marom; Gutman, Josef; Krupp, Lauren; Charvet, Leigh
BACKGROUND/UNASSIGNED:Many individuals with progressive multiple sclerosis (PMS) are challenged by reduced manual dexterity and limited rehabilitation options. Transcranial direct current stimulation (tDCS) during motor training can improve rehabilitation outcomes. We developed a protocol for remotely supervising tDCS to deliver sessions of stimulation paired with training at home. OBJECTIVE/UNASSIGNED:This study evaluated the effectiveness of at-home tDCS paired with manual dexterity training for individuals with PMS. METHODS/UNASSIGNED:Sixty-five right-hand dominant participants with PMS and hand impairment were randomized to receive either active or sham M1-SO tDCS paired with manual dexterity training over 4 weeks. Clinical outcomes were measured by the changes in Nine-Hole Peg Test (9-HPT) and Dellon-Modified-Moberg-Pick-Up Test (DMMPUT). RESULTS/UNASSIGNED:= 0.04). CONCLUSION/UNASSIGNED:At-home tDCS paired with manual dexterity training is effective for individuals with PMS, with M1-SO tDCS enhancing training outcomes and offering a promising intervention for improving and preserving hand dexterity.
PMID: 39268655
ISSN: 1477-0970
CID: 5719402
Editorial: Neurotechnology for brain-body performance and health: insights from the 2022 Neuroergonomics and NYC Neuromodulation Conference [Editorial]
Bikson, Marom; Charvet, Leigh; Pilloni, Giuseppina; Dehais, Frederic; Ayaz, Hasan
PMID: 39290527
ISSN: 2673-6195
CID: 5720772