Informed consent competency assessment for brain-computer interface clinical research and application in psychiatric disorders: A systematic review

Table 1 Informed consent competency assessment in brain computer interface research involving six major psychiatric disorders

Psychiatric disorders	BCI researches and applications	ICC challenges	ICC correlation and influence factors	Future research directions of ICC in BCI research
Schizophrenia	Non-invasive BCI: rt-fMRI neurofeedback for regulating abnormal neural connection[33]	Impaired DMC[27]	Symptoms severity correlation[27]	Expand clinical samples to include outpatients and patients with different symptom levels[27]
			Emotional processing and emotional regulation issues[28]
			Slower decision-making[27]
			Executive function impairment[27-29]
			Working memory deficit[27,29]
			Lower cognitive flexibility[27]	Explore neuroimaging integration in ICC[27]
			Auditory memory deficit[27]
			Rote memory[29]
			Visual memory deficit[29]
			Long-term memory impairment[27]
			Immediate memory impairment[27]	Include measures of motivation or effort to check for possible confounding effects[27]
			Processing speed deficit[27]
			Deficit in verbal memory and learning, semantic-categorical and phonological verbal fluency[27,29]
			Dysfunction of the orbitofrontal cortex (OFC) leads to reduced levels of ambiguous aversion[30-32]
Mood Disorders	Non-invasive BCI: aBCI using resting-state EEG for depression detection[43]	Influenced speed of decision-making but comparable advantageous choices[27]	Symptoms severity correlation[27]	Schizophrenia 1, 2, and 3 also applies to Mood Disorders[27]
			Slower decision-making[27]
			Long-term memory impairment[27]
			Immediate memory impairment[27]	Target deep brain regions using non-invasive brain stimulation methods to expand the applicability of deep brain stimulation, reduce risks, and maximize treatment effectiveness[41]
			Episodic memory impairment[35]
			Executive function deficits[27,35-38]
			Processing speed deficit[27,35]
			Verbal and non-verbal learning and memory[27]
			Variability in treatment response[27]	Developing an Emotional Blend BCI to support patients' brain activity and reduces addictive behaviors[42]
			Long-term remission maintenance[27]
			Emotional processing and emotional regulation issues[39,40]
Anorexia Nervosa	Non-invasive BCI: Rt-fMRI-BCI for self-regulation of anterior insular cortex activity[55]	Impaired DMC: Inability to make advantageous decisions, neglect of long-term consequences[46,47,51,52]	Body mass index is associated with decision-making ability[46]	Developing Personalized Intelligent Systems with BCI and Sensor Technologies[53,54]
			Impaired control system[48]	Developing mobile health technologies, digital twins, and social bots to provide real-time, personalized support for decision-making, behavior change, and daily living[53]
			Lack of feedback sensitivity[46-50]
			Overreaction to rewards associated with eating disorder behaviors[51]	Designing non-invasive brain stimulation methods to target deep brain regions can expand the use of deep brain stimulation therapy and reduce treatment risks[54]
			Anxiety and emotional dysfunction[53]
Alzheimer’s disease	Non-invasive BCI Invasive BCI[64,65]	Severely impaired DMC[62]	Executive function impaired[57,58]	Memory and Organizational Aids for Informed Consent[63]
			Short-term memory impairment[59]
			Episodic memory impairment[60,61]
			Working memory impairment[60,61]	Include neuropsychological tests to consent capacity research[62]
			Semantic knowledge impairment[59]
			Reasoning impairment[59]
			Verbal knowledge impairment[60,61]	Incorporate decision-making instrument instead of cognitive tests into clinical care[62]
			Processing speed impairment[60,61]
			Progressive cognitive decline[56,62]
			Influenced total score of the Alzheimer’s Disease Assessment Scale– Cognition (ADAS-Cog) and category fluency[57,58]
Parkinson disease	Invasive BCI[77]	Impaired DMC[67]	Dopamine deficiency impairs basal ganglia function including setting decision boundaries[67-69]	Whether dopamine itself affects using prior knowledge for decision making[67]
			Dysfunction in Basal Ganglia and Prefrontal Cortical Networks[70-72]
			Compensatory Shift to Drift Rate Adjustments[67,73]
			Impact of long-term dopamine replacement therapy[74-76]
Alcohol dependence	Non-invasive BCI: EEG-based BCI[88]	Impaired DMC: Characterized by increased risk-taking behavior and difficulty weighing long-term[79]	Executive functioning impairment[79-82]	Develop tasks that could generalize to the general spectrum of situations of decision-making under uncertainty[79]
			Working memory impairments (Storing and manipulating; Ospan Task)[79,83-87]
			Making disadvantageous decisions under ambiguity (Iowa Gambling Task)[79]	Design a task to consider interference from emotion and other cognitive processes and independently validate the effect of working memory executive function on risky decision making[79]
			Making more risky decisions under risk (Cups Task and Coin Flipping Task)[79]

BCI: Brain-computer interface; ICC: Informed consent competency; rt-fMRI: Real-time functional magnetic resonance imaging; aBCI: Affective brain-computer interface; EEG: Electroencephalogram; rTMS: Repetitive transcranial magnetic stimulation; tDCS: Transcranial direct-current stimulation; DBS: Deep brain stimulation; aDBS: Adaptive deep brain stimulation.