An interventional study of tDCS in Stroke and Hemiparesis, sponsored by Erasmus Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-11-28.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation.
Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.
Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's planned enrollment of 48 is close to the median of 50 across 5,370 interventional studies indexed under Stroke.
Browse Stroke studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Motor training of the affected upper extremity combined with sham tDCS.
Device: tDCS
Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS).
Device: tDCS
Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.
Change from baseline in Upper Extremity Fugl Meyer Assessment
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
ARAT
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
Hand grip strength
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks
10-meter walk test
Time frame: Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
EuroQol-5D
Time frame: 12 weeks
Barthel Index
Time frame: Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks
HADS
Time frame: Baseline; 4 weeks and 12 weeks
MoCA
Time frame: Baseline; 4 weeks and 12 weeks
Wong-Baker FACES Pain Rating Scale
Time frame: Every stimulation session
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center