Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate whether late LTP-like plasticity tDCS increases the
effectiveness of upper limb rehabilitation therapy after stroke.
Secondary outcome
• To investigate whether the application of tDCS in subacute stroke patients
increases quality of life, cognitive performance and depression.
• To investigate whether late LTP-like plasticity tDCS increases the
effectiveness of lower limb rehabilitation therapy after stroke.
• To investigate the safety, side effects and drop-out rates for tDCS as an
integral part of upper limb rehabilitation in the first months post stroke.
Background summary
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, we 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.
Study 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.
Intervention
Patients who are enrolled in this study will receive standard care with the
addition of two one hour tDCS sessions (sham or real stimulation) per week for
4 weeks.
Study burden and risks
All participants are stroke patients who are enrolled in Rijndam*s regular
stroke rehabilitation programme. In addition to regular treatment, tDCS is
applied twice a week for 50 minutes during which patients are allowed to watch
television, read a book or have breakfast. Furthermore, extra measurements
include arm and hand motor skill tests (T0-T4), questionnaires on quality of
life, depression and cognitive performance (T0 and T3-4) and a genetic
analysis.
Dr Molewaterplein 50
Rotterdam 3015GE
NL
Dr Molewaterplein 50
Rotterdam 3015GE
NL
Listed location countries
Age
Inclusion criteria
• Subacute stroke (within 1-3 weeks post stroke)
• Acute hemiparesis with single thromboembolic non-hemorrhagic infarction documented by a neurologist
• Aged 18-79
Exclusion criteria
• Absence of recordable MEPs from the ADM after TMS
• Absence of voluntary movement (MRC < 2)
• 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
• History of psychiatric disorders
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49887.078.14 |