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Clinical Trials/NCT03093142
NCT03093142
Completed
Not Applicable

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

Kowloon Hospital, Hong Kong1 site in 1 country45 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Kowloon Hospital, Hong Kong
Enrollment
45
Locations
1
Primary Endpoint
Change score in Trail Making Test A & B from baseline
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
December 30, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kowloon Hospital, Hong Kong
Responsible Party
Principal Investigator
Principal Investigator

Marko Chan

Principal Investigator

Kowloon Hospital, Hong Kong

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change score in Trail Making Test A & B from baseline

Time Frame: One day before the treatment , up to 4 weeks, up to 16 weeks

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.

Secondary Outcomes

  • Change score in Functional Independence Measure (FIM) from baseline(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)(One day before the treatment , up to 4 weeks, up to 16 weeks)

Study Sites (1)

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