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

Kowloon Hospital, Hong Kong

Status: Completed

Conditions: Cognitive Impairment; Stroke

Treatments: Device: sham neurofeedback; Device: tDCS & neurofeedback; Device: neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT03093142

KowloonH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

tDCS & neurofeedback

Experimental group

Description:

30 minutes tDCS \& 30 minutes neurofeedback

Treatment:

Device: tDCS & neurofeedback

real neurofeedback

Active Comparator group

Description:

30 minutes real neurofeedback.

Treatment:

Device: neurofeedback

sham neurofeedback

Sham Comparator group

Description:

30 minutes sham neurofeedback.

Treatment:

Device: sham neurofeedback