Clinical trial NCT03093142: The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke
Official title: The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cognitive Impairment
Keywords: transcranial direct current stimulation (tDCs)
neurofeedback
Lead sponsor: Kowloon Hospital, Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2017-03-28
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change score in Trail Making Test A & B from baseline
timeFrame: One day before the treatment , up to 4 weeks, up to 16 weeks
Secondary outcomes:
measure: Change score in Functional Independence Measure (FIM) from baseline
timeFrame: One day before the treatment , up to 4 weeks, up to 16 weeks
measure: Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA - SIP 30)
timeFrame: One day before the treatment , up to 4 weeks, up to 16 weeks
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Community Rehabilitation Service Support Centre
Study officials:
affiliation: Community Rehabilitation Service Supoort Centre
name: Marko Chan, PhDCandidate
role: PRINCIPAL_INVESTIGATOR
References: