Dataset Information

Transcranial direct current stimulation combined with robotic training in incomplete spinal cord injury: a randomized, sham-controlled clinical trial.

ABSTRACT:

Study design

A randomized, sham-controlled clinical trial.

Objective

To test the effects of tDCS, combined with robotic training, on gait disability in SCI. Our hypothesis was that participants who received active tDCS would experience greater walking gains, as indexed by the WISCI-II, than those who received sham tDCS.

Setting

University of São Paulo, Brazil.

Methods

This randomized, double-blind study comprised 43 participants with incomplete SCI who underwent 30 sessions of active (n = 21) or sham (n = 22) tDCS (20 min, 2 mA) before every Lokomat session of 30 min (3 times a week over 12 weeks or 5 times a week over 6 weeks). The main outcome was the improvement in WISCI-II. Participants were assessed at baseline, after 15 and 30 sessions of Lokomat, and after three months of treatment.

Results

There was a significant difference in the percentage of participants that improved in WISCI-II at the 30-session, compared with baseline: 33.3% in the sham group and 70.0% in the active group (p = 0.046; OR: 3.7; 95% CI: 1.0-13.5). At the follow-up, the improvement compared with baseline in the sham group was 35.0% vs. 68.4% for the active group (p = 0.046; OR: 3.7; 95% CI: 1.0-13.5). There was no significant difference at the 15-session.

Conclusion

Thirty sessions of active tDCS is associated with a significant improvement in walking, compared to sham. Moreover, 15 sessions had no significant effect. The improvement in WISCI-II can be related to different aspects of motor learning, including motor recovery and compensation.

SUBMITTER: Simis M

PROVIDER: S-EPMC8476486 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Publications

Transcranial direct current stimulation combined with robotic training in incomplete spinal cord injury: a randomized, sham-controlled clinical trial.

Simis Marcel M Fregni Felipe F Battistella Linamara R LR

Spinal cord series and cases 20210927 1

<h4>Study design</h4>A randomized, sham-controlled clinical trial.<h4>Objective</h4>To test the effects of tDCS, combined with robotic training, on gait disability in SCI. Our hypothesis was that participants who received active tDCS would experience greater walking gains, as indexed by the WISCI-II, than those who received sham tDCS.<h4>Setting</h4>University of São Paulo, Brazil.<h4>Methods</h4>This randomized, double-blind study comprised 43 participants with incomplete SCI who underwent 30 s ...[more]

PMID: 34580282

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Project description:Introduction: Conventional transcranial direct current stimulation (tDCS) and high-definition tDCS (HD-tDCS) may improve motor learning in children. Mechanisms are not understood. Neuronavigated robotic transcranial magnetic stimulation (TMS) can produce individualised maps of primary motor cortex (M1) topography. We aimed to determine the effects of tDCS- and HD-tDCS-enhanced motor learning on motor maps. Methods: Typically developing children aged 12-18 years were randomised to right M1 anodal tDCS, HD-tDCS, or Sham during training of their left-hand on the Purdue Pegboard Task (PPT) over 5 days. Bilateral motor mapping was performed at baseline (pre), day 5 (post), and 6-weeks retention time (RT). Primary muscle was the first dorsal interosseous (FDI) with secondary muscles of abductor pollicis brevis (APB) and adductor digiti minimi (ADM). Primary mapping outcomes were volume (mm2/mV) and area (mm2). Secondary outcomes were centre of gravity (COG, mm) and hotspot magnitude (mV). Linear mixed-effects modelling was employed to investigate effects of time and stimulation type (tDCS, HD-tDCS, Sham) on motor map characteristics. Results: Twenty-four right-handed participants (median age 15.5 years, 52% female) completed the study with no serious adverse events or dropouts. Quality maps could not be obtained in two participants. No effect of time or group were observed on map area or volume. LFDI COG (mm) differed in the medial-lateral plane (x-axis) between tDCS and Sham (p = 0.038) from pre-to-post mapping sessions. Shifts in map COG were also observed for secondary left-hand muscles. Map metrics did not correlate with behavioural changes. Conclusion: Robotic TMS mapping can safely assess motor cortex neurophysiology in children undergoing motor learning and neuromodulation interventions. Large effects on map area and volume were not observed while changes in COG may occur. Larger controlled studies are required to understand the role of motor maps in interventional neuroplasticity in children.

Project description:Importance:Aphasia is a debilitating language disorder for which behavioral speech therapy is the most efficient treatment, but therapy outcomes are variable and full recovery is not always achieved. It remains unclear if adjunctive brain stimulation (anodal transcranial direct current stimulation [A-tDCS]) applied during aphasia therapy can improve outcomes. Objective:To examine the futility of studying A-tDCS as an adjunctive intervention during speech therapy to improve speech production (naming) for individuals with long-term poststroke aphasia. Design, Setting, and Participants:Double-blinded, prospective randomized clinical trial using a futility design to test adjunctive A-tDCS during speech therapy. The setting was an outpatient clinic. Enrollment of individuals began in August 2012 and was completed in March 2017, and the duration of follow-up was 6 months. Analyses began in April 2017. The study recruited from a volunteer sample, and 89 patients were screened. Patients with long-term (>6 months) aphasia due to 1 previous left hemisphere stroke were enrolled. In comparing A-tDCS and sham tDCS, patients were matched based on site (University of South Carolina or Medical University of South Carolina), baseline age, type of aphasia, and aphasia severity. Interventions:Outpatient speech therapy for 3 weeks (15 sessions, 45 minutes each) combined with either A-tDCS vs sham tDCS applied to preserved left temporal lobe regions. Main Outcomes and Measures:The primary outcome was the ability to name common objects, assessed twice before and after therapy. Results:A total of 74 patients were enrolled. Participants had a mean (SD) age of 60 (10) years, had 15 (2) years of education, and were 44 (40) months from stroke onset. There were 52 men (70%) and 62 non-Hispanic white individuals (84%). Most were retired or not employed (59 [80%]). Broca aphasia was the most common aphasia type (39 [52.7%]). The adjusted mean (SE) change from pretreatment baseline in correct naming was 13.9 (2.4) words (95% CI, 9.0-18.7) for A-tDCS and 8.2 (2.2) words (95% CI, 3.8-12.6) for sham tDCS, with mean (SE) A-tDCS difference of 5.7 (3.3) words (95% CI, -0.9 to 12.3), indicating a relative 70% increase in correct naming for A-tDCS relative to sham. The futility hypothesis P value was .90, indicating failure to reject the null hypothesis and, therefore, providing no evidence that further study of A-tDCS is futile. No serious adverse events were associated with A-tDCS. Conclusions and Relevance:Our findings provide motivation to proceed with another trial to study the effect of A-tDCS on the outcome of aphasia treatment in individuals poststroke. Anodal tDCS during speech therapy is feasible and potentially transformative for aphasia treatment and should be further studied. Trial Registration:ClinicalTrials.gov Identifier: NCT01686373.

Dataset Information

Transcranial direct current stimulation combined with robotic training in incomplete spinal cord injury: a randomized, sham-controlled clinical trial.

Study design

Objective

Setting

Methods

Results

Conclusion

Publications

Transcranial direct current stimulation combined with robotic training in incomplete spinal cord injury: a randomized, sham-controlled clinical trial.

Similar Datasets

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