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<p><b>Objective.</b> To evaluate the tolerability and safety of using high-tech software packages with biofeedback (BFB) via a brain–computer interface (BCI) in the rehabilitation of patients after stroke based on analysis of neuropsychological examination data. <b>Materials and methods.</b> A total of 100 stroke patients were examined: the study group consisted of 40 patients, the reference group consisted of 40 patients, and the control group consisted of 20 subjects. The Hospital Anxiety and Depression Scale (HADS), the Beck Depression Inventory (BDI), the Hamilton Anxiety Rating Scale (HARS), the Hamilton Depression Rating Scale (HDRS), the Montreal Cognitive Assessment (MoCA), and the Mini-Mental State Examination (MMSE) were used. The study group took part in sessions using the BCI-BFB1, which is based on the P300 potential; the reference group took part in sessions using the BCI-BFB2, which is based on the mu rhythm detected by electroencephalography (EEG); the control group received standard therapy. <b>Results.</b> Improvements were seen in assessments of subjective symptoms; there was no “worsening of/increase in” existing symptoms or emergence of new symptoms, which indicated good tolerability when using the BCI BFB1 or the BCI-BFB2. The results of assessments on the BDI, HARS, and HDRS scales demonstrated statistically significant improvements in indicators, indicating regression of existing affective disorders to a level corresponding to minor disorders, namely “subclinical anxiety/depression” (<i>p</i> &lt; 0.001). Assessment on the BDI and HDRS scales showed statistically significant changes consisting of decreases in scores on the affective-cognitive disorders subscale in the study group (<i>p</i> = 0.002) and the reference group (<i>p</i> &lt; 0.001). MoCA assessment showed that with initial scores of ≥25 points, there was no decrease in score: in the study group there was an increase in the median total score (<i>p</i> = 0.014), while there was no change in the reference group (<i>p</i> = 0.683). <b>Conclusions.</b> Treatment including BCI-BFB1, based on P300, and BCI-BFB2, based on the EEG mu rhythm, was safe in patients in the recovery period of stroke, showed good tolerability, did not cause the appearance of or increases in affective disorders, and did not reduce scores on the MoCA scale.</p>

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Spectrum of Tolerability and Safety of the Use of Brain–Computer Interfaces with Biofeedback in Cognitive Rehabilitation after Stroke

  • 期刊论文

  • 发表日期：

    2026年7月27日

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  • S. V. Kotov,
  • E. V. Isakova,
  • V. A. Borisova

摘要

Objective. To evaluate the tolerability and safety of using high-tech software packages with biofeedback (BFB) via a brain–computer interface (BCI) in the rehabilitation of patients after stroke based on analysis of neuropsychological examination data. Materials and methods. A total of 100 stroke patients were examined: the study group consisted of 40 patients, the reference group consisted of 40 patients, and the control group consisted of 20 subjects. The Hospital Anxiety and Depression Scale (HADS), the Beck Depression Inventory (BDI), the Hamilton Anxiety Rating Scale (HARS), the Hamilton Depression Rating Scale (HDRS), the Montreal Cognitive Assessment (MoCA), and the Mini-Mental State Examination (MMSE) were used. The study group took part in sessions using the BCI-BFB1, which is based on the P300 potential; the reference group took part in sessions using the BCI-BFB2, which is based on the mu rhythm detected by electroencephalography (EEG); the control group received standard therapy. Results. Improvements were seen in assessments of subjective symptoms; there was no “worsening of/increase in” existing symptoms or emergence of new symptoms, which indicated good tolerability when using the BCI BFB1 or the BCI-BFB2. The results of assessments on the BDI, HARS, and HDRS scales demonstrated statistically significant improvements in indicators, indicating regression of existing affective disorders to a level corresponding to minor disorders, namely “subclinical anxiety/depression” (p < 0.001). Assessment on the BDI and HDRS scales showed statistically significant changes consisting of decreases in scores on the affective-cognitive disorders subscale in the study group (p = 0.002) and the reference group (p < 0.001). MoCA assessment showed that with initial scores of ≥25 points, there was no decrease in score: in the study group there was an increase in the median total score (p = 0.014), while there was no change in the reference group (p = 0.683). Conclusions. Treatment including BCI-BFB1, based on P300, and BCI-BFB2, based on the EEG mu rhythm, was safe in patients in the recovery period of stroke, showed good tolerability, did not cause the appearance of or increases in affective disorders, and did not reduce scores on the MoCA scale.