Dataset Information

Home-based tDCS for apathy in Alzheimer's disease: a protocol for a randomized double-blinded controlled pilot study.

ABSTRACT:

Background

Apathy is among the most common behavioral symptoms in dementia and is consistently associated with negative outcomes in Alzheimer's disease (AD). Despite its prevalence and clinical relevance, available pharmacological and non-pharmacological strategies to treat apathy in AD have been marked, respectively, by potentially severe side effects and/or limited efficacy. Transcranial direct current stimulation (tDCS) is a relatively novel non-pharmacological method of neuromodulation with promising results. Compared to previous tDCS formats, recent technological advances have increased the portability of tDCS, which creates the potential for caregiver-administered, home use. Our study aims to evaluate the feasibility, safety, and efficacy of home-based tDCS for the treatment of apathy in AD.

Methods/design

This is an experimenter- and participant-blinded, randomized, sham-controlled, parallel-group (1:1 for two groups) pilot clinical trial, involving 40 subjects with AD. After a brief training, caregivers will administer tDCS for participants at home under remote televideo supervision by research staff to ensure the use of proper technique. Participants will be assessed at baseline, during treatment (week 2, week 4, and week 6), and 6 weeks post-treatment. Dependent measures will cover cognitive performance, apathy, and other behavioral symptoms. Data about side effects and acceptability will also be collected.

Discussion

Our study will address apathy, an overlooked clinical problem in AD. Our findings will advance the field of non-pharmacological strategies for neuropsychiatric symptoms, presenting a great potential for clinical translation.

Trial registration

ClinicalTrials.gov, NCT04855643.

SUBMITTER: Teixeira AL

PROVIDER: S-EPMC10161588 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Home-based tDCS for apathy in Alzheimer's disease: a protocol for a randomized double-blinded controlled pilot study.

Teixeira Antonio L AL Martins Laís Bhering LB Cordeiro Thiago Macedo E TME Jose Lijin L Suchting Robert R Holmes Holly M HM Acierno Ron R Ahn Hyochol H

Pilot and feasibility studies 20230505 1

<h4>Background</h4>Apathy is among the most common behavioral symptoms in dementia and is consistently associated with negative outcomes in Alzheimer's disease (AD). Despite its prevalence and clinical relevance, available pharmacological and non-pharmacological strategies to treat apathy in AD have been marked, respectively, by potentially severe side effects and/or limited efficacy. Transcranial direct current stimulation (tDCS) is a relatively novel non-pharmacological method of neuromodulati ...[more]

PMID: 37147739

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Project description:BackgroundCurrently, there are no FDA approved therapies for persistent post-traumatic headache (PPTH) secondary to traumatic brain injury (TBI). As such neither headache nor TBI specialists have an effective means to manage PPTH. Thus, the objective of the present pilot trial was to evaluate the feasibility and preliminary efficacy of a four-week at-home remotely supervised transcranial direct current stimulation (RS-tDCS) intervention for veterans with PPTH.MethodsTwenty-five (m = 46.6 ± 8.7 years) veterans with PPTH were randomized into two groups and received either active (n = 12) or sham (n = 13) RS-tDCS, with anodal stimulation over left dlPFC and cathodal over occipital pole. Following a four-week baseline, participants completed 20-sessions of active or sham RS-tDCS with real-time video monitoring over a period of four-weeks. Participants were assessed again at the end of the intervention and at four-weeks post-intervention. Primary outcomes were overall adherence rate (feasibility) and change in moderate-to-severe headache days per month (efficacy). Secondary outcomes were changes in total number of headache days, and PPTH-related functional outcomes.ResultsAdherence rate was high with 88% of participants (active = 10/12; sham = 12/13) fully completing tDCS interventions. Importantly, there was no significant difference in adherence between active and sham groups (p = 0.59). Moderate-to-severe headache days were significantly reduced within the active RS-tDCS group (p = 0.004), compared to sham during treatment (-2.5 ± 3.5 vs. 2.3 ± 3.4), and 4-week follow-up (-3.9 ± 6.4 vs. 1.2 ± 6.5). Total number of headache days was significantly reduced within the active RS-tDCS (p = 0.03), compared to sham during-treatment (-4.0 ± 5.2 vs. 1.5 ± 3.8), and 4-week follow-up (-2.1 ± 7.2 vs. -0.2 ± 4.4).ConclusionThe current results indicate our RS-tDCS paradigm provides a safe and effective means for reducing the severity and number of headache days in veterans with PPTH. High treatment adherence rate and the remote nature of our paradigm indicate RS-tDCS may be a feasible means to reduce PPTH, especially for veterans with limited access to medical facilities.Clinical Trial Registration: ClinicalTrials.gov, identifier [NCT04012853].

Project description:ObjectivesViscosupplementation with new-generation, polyol-containing, cross-linked hyaluronic acid (HA) gels reduces joint inflammation in patients with knee osteoarthritis. Gait analysis is a complementary outcome measure to standard patient-reported scores and physical measures for testing the effect of HA injection. This three-arm, prospective, randomized, controlled, double-blind, feasibility pilot study investigated which gait parameters are more sensitive following a single bolus injection of polyol-containing HA for knee osteoarthritis.MethodsTwenty-two patients with Ahlbäck grade II-III knee osteoarthritis were randomly allocated into three groups: (1) HA + mannitol (n = 9), (2) HA + sorbitol (n = 5), and (3) saline placebo (n = 8). Patients were assessed by blinded observers prior to injection and at 4 weeks post-injection (4W). Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Society score (KSS), EuroQol in five-dimensions (EQ-5D), VAS pain, and VAS stiffness. Gait was assessed over 30 m using a portable inertial-based data logger (Physilog®).ResultsDifferences between 4W and baseline were statistically significant for the mannitol-containing viscosupplement, with a median increase of 0.076 m/s on gait speed (p = 0.039), 0.055 m on stride length (p = 0.027), and 15 points on the KSS (p = 0.047). In contrast, the HA + sorbitol and saline groups demonstrated no significant changes from baseline to 4W in any gait parameters or self-reported outcome measures (all p > 0.3). The observed increase in gait speed is approximately 13% greater than the mean difference between healthy subjects and those with knee osteoarthritis, is clinically important, and thus is a sensitive gait parameter.ConclusionsThis study demonstrated gait speed and stride length are the most relevant gait parameters to investigate when assessing the effect of polyol-containing HA viscosupplementation. This study supports the need for a larger, randomized, controlled, clinical trial to assess the effect of a single-bolus HA injection versus multiple injections in people with knee osteoarthritis using both gait performance and self-reported parameters of knee function.Trial registrationThis study was retrospectively registered at clinicaltrials.gov on August 20, 2018, and assigned #NCT03636971.Level of evidenceI.

Project description:BackgroundDual transcranial direct current stimulation (tDCS) over the bilateral primary somatosensory cortex (PSC) has potential benefits in stroke. In addition, compared with traditional rehabilitation training, sensorimotor training can significantly improve the sensorimotor function of patients. However, the efficacy of dual-tDCS combined with sensorimotor training in patients with subacute stroke is unknown.ObjectiveTo assess whether dual-tDCS may enhance the efficacy of sensorimotor training on the upper limb functions in patients with subacute stroke. In addition, this study aims to explore the potential clinical mechanism of this combination therapy.MethodsWe randomized 52 individuals with first-ever, unilateral subcortical stroke into the experimental group (n = 26) and the control group (n = 26). Patients in the experimental group received 20 min of dual-tDCS over the PSC and 40 min of sensorimotor training each session, while patients in the control group received sham dual-tDCS. The treatment cycle was a 1-h session of therapy each day, 5 days per week for 4 weeks. The Fugl-Meyer Assessment of Upper Extremity (FMA-UE) subscale, Action Research Arm Test (ARAT), Box and Block test (BBT), Erasmus MC revised Nottingham sensory assessment scale (Em-NSA), Neurometer sensory nerve quantitative detector (CPT), the Barthel index (BI), and Hospital Anxiety and Depression Scale (HADS) were used to assess upper limb function, activities of daily living (ADL), and mental health before and after the 4-week treatment period. In addition, functional near-infrared spectroscopy (fNIRS) was used to explore potential clinical brain mechanisms.ResultsBoth groups showed significant improvement in all clinical scales (All p < 0.05) after treatment. Compared with sham-tDCS plus sensorimotor training, active dual-tDCS coupled with sensorimotor training can significantly improve the FMA-UE, ARAT, Em-NSA-Stereognosis, and CPT-2K Hz. In addition, dual-tDCS combined with sensorimotor training can significantly activate the left pre-Motor and supplementary motor cortex (PM-SMC) and enhance the functional connection between the left somatosensory association cortex (SAC) and RPM-SMC. Furthermore, the difference of FMA-UE in the experimental group was positively correlated with the functional connectivity of RPM-SMC-LSAC (r = 0.815, p < 0.001).ConclusionDual-tDCS over the PSC combined with sensorimotor training can improve upper limb sensory and motor dysfunction, enhance ADL, and alleviate depression and anxiety for subacute stroke patients. Our results indicated that RPM-SMC-LSAC may be potential therapeutic targets for dual-tDCS in upper limb rehabilitation on stroke.

Project description:IntroductionKnee osteoarthritis (OA) represents a leading cause of disability globally. Exercise has been demonstrated to improve pain and function in people with knee OA. However, when in pain, commencement of exercise is difficult, and clinical effects with such interventions are often modest. Recently, transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, has been shown to bolster the pain-relieving effect of exercise in experimental settings. While promising, the utility of employing this approach beyond the research environment is yet to be elucidated. Therefore, this pilot study aims to investigate the feasibility, safety, adherence, tolerability and preliminary efficacy of tDCS and exercise in home-based settings to improve pain and function in people with knee OA.Methods and analysisThis protocol is for a pilot randomised, double-blinded, sham-controlled trial. 24 individuals with idiopathic knee OA will be randomised to receive either active tDCS+exercise (Intervention) or sham tDCS+exercise (Control) at home. Participants will receive 20 min of tDCS 5 days per week for the first 2 weeks of this 8-week trial. Participants in both groups will complete a lower limb strengthening programme 3 days per week for the entire 8 weeks. Outcome measures of feasibility (acceptability, satisfaction, retention), safety, adherence and tolerability will be assessed throughout the trial period, with clinical outcomes of pain and function assessed before and following the intervention. Feasibility, safety, adherence and tolerability outcomes will be explored descriptively using frequencies and percentages. To examine preliminary efficacy, within-group and between-group changes in pain and functional measures will be analysed.Ethics and disseminationThis protocol obtained ethical approval from the Queensland University of Technology Human Research Ethics Committee (HREA 2024-8302-20200). All participants will provide written informed consent. The findings of the study will be disseminated via journal publications and international conference proceedings.Trial registration numberACTRN12624000397516p.

Project description:BackgroundDiabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus (T2DM); its diagnosis and treatment are based on symptomatic improvement. However, as pharmacological therapy causes multiple adverse effects, the implementation of acupunctural techniques, such as electroacupuncture (EA) has been suggested as an alternative treatment. Nonetheless, there is a lack of scientific evidence, and its mechanisms are still unclear. We present the design and methodology of a new clinical randomized trial, that investigates the effectiveness of EA for the treatment of DPN.MethodsThis study is a four-armed, randomized, controlled, multicenter clinical trial (20-week intervention period, plus 12 weeks of follow-up after concluding intervention). A total of 48 T2DM patients with clinical signs and symptoms of DPN; and electrophysiological signs in the Nerve Conduction Study (NCS); will be treated by acupuncture specialists in outpatient units in Mexico City. Patients will be randomized in a 1:1 ratio to one of the following four groups: (a) short fibre DPN with EA, (b) short fibre DPN with sham EA, (c) axonal DPN with EA and (d) axonal DPN with sham EA treatment. The intervention will consist of 32 sessions, 20 min each, per patient over two cycles of intervention of 8 weeks each and a mid-term rest period of 4 weeks. The primary outcome will be NCS parameters, and secondary outcomes will include DPN-related symptoms and pain by Michigan Neuropathy Screening Instrument (MNSI), Michigan Diabetic Neuropathy Score (MDNS), Dolour Neuropatique Score (DN-4), Semmes-Westein monofilament, Numerical Rating Scale (NRS) for pain assessment, and the 36-item Short Form Health Survey (SF-36). To measure quality of life and improve oxidative stress, the inflammatory response; and genetic expression; will be analysed at the beginning and at the end of treatment.DiscussionThis study will be conducted to compare the efficacy of EA versus sham EA combined with conventional diabetic and neuropathic treatments if needed. EA may improve NCS, neuropathic pain and symptoms, oxidative stress, inflammatory response, and genetic expression, and it could be considered a potential coadjutant treatment for the management of DPN with a possible remyelinating effect.Trial registrationClinicalTrials.gov. NCT05521737 Registered on 30 August 2022. International Clinical Trials Registry Platform (ICTRP) ISRCTN97391213 Registered on 26 September 2022 [2b].

Project description:The application of transcranial direct current stimulation (tDCS) at home for the treatment of major depressive disorder (MDD) is the subject of current clinical trials. This is due to its positive safety profile, cost-effectiveness, and potential scalability for a wide outreach in clinical practice. Here, we provide a systematic review of the available studies and also a report on the results of a randomized controlled trial (RCT) on tDCS at home for the treatment of MDD. This trial had to be prematurely terminated due to safety concerns. The HomeDC trial is a double-blinded, placebo-controlled, parallel-group study. Patients with MDD (DSM-5) were randomized to active or sham tDCS. Patients conducted tDCS at home for 6 weeks with 5 sessions/week (30 min at 2 mA) anode over F3, cathode over F4. Sham tDCS resembled active tDCS, with ramp-in and ramp-out periods, but without intermittent stimulation. The study was prematurely terminated due to an accumulation of adverse events (AEs, skin lesions), so that only 11 patients were included. Feasibility was good. Safety monitoring was not sufficient enough to detect or prevent AEs within an appropriate timeframe. Regarding antidepressant effects, the reduction in depression scales over time was significant. However, active tDCS was not superior to sham tDCS in this regard. Both the conclusions from this review and the HomeDC trial show that there are several critical issues with the use of tDCS at home that need to be addressed. Nevertheless the array of transcranial electric simulation (TES) methods that this mode of application offers, including tDCS, is highly interesting and warrants further investigation in high quality RCTs.Trial registrationwww.Clinicaltrialsgov .Trial registration numberNCT05172505. Registration date: 12/13/2021, https://clinicaltrials.gov/ct2/show/NCT05172505 . *Consider, if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers) **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71 . For more information, visit: http://www.prisma-statement.org/.

Dataset Information

Home-based tDCS for apathy in Alzheimer's disease: a protocol for a randomized double-blinded controlled pilot study.

Background

Methods/design

Discussion

Trial registration

Publications

Home-based tDCS for apathy in Alzheimer's disease: a protocol for a randomized double-blinded controlled pilot study.

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