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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-12-30

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.

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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.

Conditions

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Stroke Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tDCS & neurofeedback

30 minutes tDCS \& 30 minutes neurofeedback

Group Type EXPERIMENTAL

tDCS & neurofeedback

Intervention Type DEVICE

tDCs and neurofeedback

real neurofeedback

30 minutes real neurofeedback.

Group Type ACTIVE_COMPARATOR

neurofeedback

Intervention Type DEVICE

Neurofeedback

sham neurofeedback

30 minutes sham neurofeedback.

Group Type SHAM_COMPARATOR

sham neurofeedback

Intervention Type DEVICE

sham neurofeedback

Interventions

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tDCS & neurofeedback

tDCs and neurofeedback

Intervention Type DEVICE

neurofeedback

Neurofeedback

Intervention Type DEVICE

sham neurofeedback

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging
2. Below 16 th percentile cut off in Hong Kong Montreal - Cognitive Assessment (HK - MoCA) (range from 17-25/30).
3. Less than twelve months since onset of stroke at study entry
4. Able to follow simple command

Exclusion Criteria

1. Patients with severe dysphasia (either expressive or comprehensive) which restricts communication;
2. History of other neurological disease, psychiatric disorder, or alcoholism;
3. Significant impairment in visual or auditory function
4. Any additional medical or psychological condition that would affect their ability to comply with the study protocol.

Eligible Sex

ALL

Accepts Healthy Volunteers

No