To investigate whether the application of dual-site tACS during cognitive training ameliorates spatial neglect symptoms to a larger extent than the application of sham stimulation during cognitive training.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate whether the application of dual-site transcranial alternating
current stimulation during cognitive training improves spatial neglect symptoms
to a larger extent than the application of sham stimulation during cognitive
training.
Secondary outcome
To investigate whether the application of dual-site transcranial alternating
current stimulation during cognitive training ameliorates neglect behaviour in
activities of daily living (ADL) to a larger extent than the application of
sham stimulation during cognitive training.
Background summary
Hemispatial neglect is a common symptom in stroke patients and is marked by the
inability to attend to the contralesional side of space. The standard cognitive
training for neglect in the subacute phase of stroke is visual scanning
training (VST). However, VST requires many sessions to have a long-lasting
effect. Here, we aim to increase the effectiveness of VST by applying
transcranial Alternating Current Stimulation (tACS) to the frontoparietal
attention network in patients with neglect following subacute stroke.
Study objective
To investigate whether the application of dual-site tACS during cognitive
training ameliorates spatial neglect symptoms to a larger extent than the
application of sham stimulation during cognitive training.
Study design
Double-blind randomized placebo-controlled intervention study. After enrolment
and completion of baseline measurements, patients are randomly assigned to
either the active tACS group or sham (control) group.
Intervention
We will combine an evidence based VST with 30 minutes of (active or sham)
dual-site tACS at theta frequency. The intervention is administered 5 times a
week for a duration of 2 weeks.
Study burden and risks
The risks of tACS are very small. The occurrence of any severe adverse
consequence of this intervention on stroke recovery has never been reported in
any clinical transcranial electrical stimulation (tES) study so far. Only minor
side effects of tES such as a slight tingling or itching sensation at the
stimulation site that disappears within the first minutes have been reported by
participants. Other minor side effects include a burning sensation, mild
headache, nausea, and fatigue.
Concerning benefits associated with participation, we expect an improvement of
neglect-related symptoms and neglect behaviour in daily life situations after
10 sessions of VST with tACS treatment compared to sham stimulation. Concerning
discomforts, a conductive paste is applied to the tACS to stick them to the
scalp of the patient. After the session has ended the patient will be given the
opportunity to wash his/her hair.
Oxfordlaan 55
Maastricht 6229 EV
NL
Oxfordlaan 55
Maastricht 6229 EV
NL
Listed location countries
Age
Inclusion criteria
- 30-80 years of age
- Subacute stroke (stroke occurred more than 2 weeks and less than 6 months
ago; first or recurrent, ischemic or intracerebral haemorrhagic lesion)
- Diagnosed visuospatial neglect and/or spatial neglect symptoms (either left
or right sided) on the basis of clinical judgement (i.e. by the cooperating
clinical (neuro)psychologist based on intake and neuropsychological assessment).
- Sufficient comprehension and communication skills to benefit from training,
on the basis of clinical judgement
(i.e. by the cooperating clinical (neuro)psychologist based on intake and
neuropsychological assessment).
Exclusion criteria
- Physically or mentally unable to participate (e.g. to perform the neglect
training)
- Severe communicative disability, including aphasia
- Local scalp injuries
- Eczema on scalp or psoriasis
- (Neuro)psychiatric or neurodegenerative diseases including epilepsy (in case
patient had one or more seizures in the last 2 years and/or had anti-epileptic
medication in the last 2 years), dementia, serious depression, multiple
sclerosis, Parkinson*s disease, Huntington*s disease on the basis of clinical
judgement (i.e. cooperating (neuro)psychologist)
- Current alcohol and/or drug abuse or a history of abuse within the last 6
months
- Pregnancy
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 | NL71371.068.19 |
| Other | NL8145 |