to investigate (1) the additional effect of tDCS on language and communication, when administered during aphasia therapy in the sub-acute phase post stroke (2) its cost-effectiveness, (3) its effect on neural reorganisation of language, and (4) the…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Boston Naming Test (BNT)
Secondary outcome
Amsterdam Nijmegen Test voor Alledaagse Taalvaardigheden (ANTAT)
EuroQOL-5D; Stroke and Aphasia Quality of Life Scale (SAQOL)
Werk en Zorg vragenlijst
Size and location of the lesion
fMRI: Laterality index (only for participants from the Rijndam rehabilitation
center)
Background summary
Recent studies have shown that transcranial Direct Current Stimulation may
enhance the effect of aphasia treatment in people with post-stroke aphasia.
tDCS is promising as a clinical tool, because it is inexpensive and easy to
apply. So far, beneficial effects have been reported in small scale studies,
mostly of people with chronic aphasia (> 1 year post onset). It is important to
investigate the potential benefits of tDCS in people with sub-acute aphasia as
well, as the larger proportion of language treatment for stroke patients is
provided in the sub-acute phase, during the first weeks and months post stroke.
Study objective
to investigate (1) the additional effect of tDCS on language and communication,
when administered during aphasia therapy in the sub-acute phase post stroke (2)
its cost-effectiveness, (3) its effect on neural reorganisation of language,
and (4) the side effects and drop out rates.
Study design: double-blind, randomized sham-controlled intervention study with
6 months follow-up.
Study design
double-blind, randomized sham-controlled intervention study with 6 months
follow-up.
Intervention
The experimental group receives language training + tDCS (transcranial Direct
Current Stimulation; 20 min, 1mA: 2x 5 therapy sessions).
The control group receives language training + StDCS (Sham transcranial Direct
Current Stimulation, i.e. inactive stimulation; 20 min, 1mA: 2x 5 therapy
sessions)
Study burden and risks
All participants are enrolled in Rijndam*s regular stroke rehabilitation
programme/Libra's regular stroke rehabilitation/Revant's regular stroke
rehabilitation/De Hoogstraat's regular stroke rehabilitation programme. The
application of tDCS during language training, is an additional treatment, which
is expected to enhance the effect of their language training. tDCS is reported
to be safe; side-effects are mild. For this study, extra test sessions are
scheduled, constituting an extra burden for the participant. All formal tests
are aphasia tests that are validated for this population and commonly used in
regular practice. In addition, participants will get several questionnaires.
In addition, 2 fMRI scans are performed during the study (only for participants
from the Rijndam rehabilitation center).
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Aphasia after stroke
Time post onset < 3 months
Age 18-80 years
Right handed
Physical health sufficient to participate in intensive aphasia therapy
Exclusion criteria
Subarachnoïd Haemorrhage (SAH)
Prior stroke resulting in aphasia
Brain surgery in the past
Epileptic activity in the past 12 months
Excessive use of alcohol or drugs
Insufficient level of Dutch premorbidly
Premorbid (suspected) dementia
Premorbid psychiatric disease affecting communication
Severe nonlinguistic cognitive disturbances impeding language therapy
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 | NL44115.078.13 |