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Background Stroke is a leading cause of neurological impairments in language, motor and cognitive functions. Next to traditional stroke treatment, Non-Invasive Brain Stimulation (NIBS) offers the potential to facilitate stroke recovery as a complementary approach. Here, we aim at exploiting the principles of NIBS, specifically transcranial Alternating Current Stimulation (tACS), to promote functional recovery of people with neglect symptoms following stroke.
Objective To determine whether neglect training complemented with tACS treatment in chronic stroke patients suffering from neglect improves neglect-related symptoms compared to neglect training with sham stimulation.
Study design Double-blind randomized placebo-controlled intervention study. After enrollment and completion of baseline measurements, participants are randomly assigned to either the active tACS group or sham (control) group.
Intervention We will combine an evidence based visual scanning training (VST) with 40 minutes of (active or sham) tACS at alpha frequency. The intervention is administered three times a week for a duration of six weeks.
Outcomes of the study Performance on standard, conventional neuropsychological tests, as well as on ADL observation scales.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tACS | Experimental |
| |
| Sham tACS | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Alternating Current Stimulation (tACS) | Device | Stimulation frequency and peak-to-peak intensity will be set to 10Hz and 1.5 milliampere (mA), phase offset will be set to 0 and 100 cycles will be used for ramping up. At the start of the neglect training session, the tACS will be started. When the neglect training session is finished, after maximally 40 minutes, the tACS will be switched off. |
| Measure | Description | Time Frame |
|---|---|---|
| Star Cancellation Task | Quality of search score | Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training. |
| Measure | Description | Time Frame |
|---|---|---|
| Computerized Visual Detection Task | Sum of weighted hits | Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training. |
| McIntosh Line Bisection Task-digitized |
| Measure | Description | Time Frame |
|---|---|---|
| EEG | Power of alpha frequency band | Testing will take place before the training (T0; baseline), and after the eighteenth (T3) training session. |
Inclusion Criteria:
Exclusion Criteria:
currently engaging in cognitive rehabilitation treatment or neglect treatment;
physically or mentally unable to participate (based on clinical judgment);
hemianopsia (based on clinical judgement);
severe communicative disability, as task descriptions need to be understood;
local scalp injuries*;
eczema on scalp or psoriasis*;
diagnosed (neuro)psychiatric or neurodegenerative diseases*;
current alcohol and/or drug abuse*; and
pregnancy*.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander T. Sack, PhD | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Limburg | 6200 MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39301290 | Derived | Middag-van Spanje M, Nijboer TCW, Schepers J, van Heugten C, Sack AT, Schuhmann T. Alpha transcranial alternating current stimulation as add-on to neglect training: a randomized trial. Brain Commun. 2024 Aug 30;6(5):fcae287. doi: 10.1093/braincomms/fcae287. eCollection 2024. | |
| 36324088 | Derived | Middag-van Spanje M, Schuhmann T, Nijboer T, van der Werf O, Sack AT, van Heugten C. Study protocol of transcranial electrical stimulation at alpha frequency applied during rehabilitation: A randomized controlled trial in chronic stroke patients with visuospatial neglect. BMC Neurol. 2022 Nov 2;22(1):402. doi: 10.1186/s12883-022-02932-7. |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| Visual Scanning Training (VST) | Behavioral | The most common treatment for neglect is VST, which is an intensive compensation training (see Dutch guidelines for rehabilitation of neglect: Ten Brink, Van Kessel, & Nijboer, 2017). The aim of this training is to improve visual scanning behavior, that is, to encourage neglect patients to actively and consciously pay attention to stimuli on the contralesional side. |
|
Endpoint weightings bias |
| Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training. |
| Schenkenberg Line Bisection Task | Relative deviation score | Testing will take place before the training (T0; baseline), after the first (T1), ninth (T2), and eighteenth (T3) training session, as well as one week (T4) and three months (T5) after termination of the training. |
| Baking Tray Task | Average x-coordinate | Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training. |
| Catherine Bergego Scale | Total score. The CBS is a 10-item observation scale, and results in a total score of 0 (no neglect) to 30 (severe neglect). | Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training. |
| Subjective Neglect Questionnaire | Total score. The SNQ is a 19-item questionnaire, and results in a total score of 19 (no reported problems) to 95 (many/frequently reported problems). | Testing will take place before the training (T0; baseline), after the ninth (T2) training session, as well as one week (T4) and three months (T5) after termination of the training. |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |