The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke

Study Overview
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Brief Summary
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This is a double blinded, randomized control trial with a pretest-posttest control and interventional groups design. Both the assessor and participants are blinded to all assessments and evaluations. All patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened initially by a series of screening test. Suitable patients are assigned randomly to 3 groups respectively. Group 1 is the combined transcranial direct current stimulation (tDCS) and neurofeedback group. Group 2 is the neurofeedback group. Group 3 is the control group with sham neurofeedback training.

Detailed Description
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Treatment sessions for all three groups are conducted by the investigators who has training in neurofeedback and transcranial direct current stimulation (tDCs). Each participant performed 10 training sessions on different days. Sessions were conducted 3-5 times a week The tDCS + neurofeedback group will carry out 30 minutes tDCS and 30 minutes neurofeedback training. The real neurofeedback group will carry out 30 minutes neurofeedback training. The sham neurofeedback group will conduct the 30 minutes sham neurofeedback training.

Official Title
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The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke

Conditions
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Stroke, Cognitive Impairment

Intervention / Treatment
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* Device: tDCS & neurofeedback
* Device: neurofeedback
* Device: sham neurofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging Below 16 th percentile cut off in Hong Kong Montreal - Cognitive Assessment (HK - MoCA) (range from 17-25/30). Less than twelve months since onset of stroke at study entry Able to follow simple command Exclusion Criteria: Patients with severe dysphasia (either expressive or comprehensive) which restricts communication; History of other neurological disease, psychiatric disorder, or alcoholism; Significant impairment in visual or auditory function Any additional medical or psychological condition that would affect their ability to comply with the study protocol.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS & neurofeedback<br>30 minutes tDCS & 30 minutes neurofeedback | Device: tDCS & neurofeedback<br>* tDCs and neurofeedback<br>|
| Active Comparator: real neurofeedback<br>30 minutes real neurofeedback. | Device: neurofeedback<br>* Neurofeedback<br>|
| Sham Comparator: sham neurofeedback<br>30 minutes sham neurofeedback. | Device: sham neurofeedback<br>* sham neurofeedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change score in Trail Making Test A & B from baseline | Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. | One day before the treatment , up to 4 weeks, up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change score in Executive function performance Test (EFPT) from baseline | The Executive Function Performance Test is a performance-based assessment of executive function through observation of four Instrumental Activities of Daily Living. | One day before the treatment , up to 4 weeks, up to 16 weeks | 
| Change score in Functional Independence Measure (FIM) from basline | The Functional Independence Measure instrument is a basic indicator of patient disability. FIM is used to track the changes in the functional ability of a patient during an episode of hospital rehabilitation care. | One day before the treatment , up to 4 weeks, up to 16 weeks | 
| Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA - SIP 30) | SA-SIP 30 assesses quality of life in patients who have sustained a stroke. | One day before the treatment , up to 4 weeks, up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation (tDCs), neurofeedback