Hemiparesis, Stroke
Conditions
Brief summary
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.
Interventions
DEVICEtDCS
Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Subacute stroke (within 1-4 weeks post stroke) * Acute hemiparesis (Fugl-Meyer Stage \< IV) with single thromboembolic non-hemorrhagic infarction documented by a neurologist * Aged 18-79
Exclusion criteria
* Absence of voluntary movement (Fugl-Meyer Stage \< III) * Head injury or the presence of intracranial metal or intracranial lesions * History of cranial irradiation * History of epilepsy * Presence of a pacemaker * Taking anticonvulsant or neuroleptic medication * Substance abuse * Inability to understand instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Upper Extremity Fugl Meyer Assessment | Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Hand grip strength | Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks |
| 10-meter walk test | Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks |
| EuroQol-5D | 12 weeks |
| ARAT | Baseline, 1 week, 2 weeks, 4 weeks and 12 weeks |
| HADS | Baseline; 4 weeks and 12 weeks |
| MoCA | Baseline; 4 weeks and 12 weeks |
| Wong-Baker FACES Pain Rating Scale | Every stimulation session |
| Barthel Index | Baseline; 1 week, 2 weeks, 4 weeks and 12 weeks |
Countries
Netherlands
Contacts
Primary ContactRick van der Vliet, MSc
Outcome results
None listed