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

March 4, 2024 updated by: Marko Chan, Kowloon Hospital, Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • Community Rehabilitation Service Support Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS & neurofeedback
30 minutes tDCS & 30 minutes neurofeedback
Device: tDCS & neurofeedback
tDCs and neurofeedback
Active Comparator: real neurofeedback
30 minutes real neurofeedback.
Device: neurofeedback
Neurofeedback
Sham Comparator: sham neurofeedback
30 minutes sham neurofeedback.
Device: sham neurofeedback
sham neurofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Stroke Adapted 30 item version of the Sickness Impact Profile (SA - SIP 30)
Time Frame: One day before the treatment , up to 4 weeks, up to 16 weeks
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
Change score in Functional Independence Measure (FIM) from baseline
Time Frame: One day before the treatment , up to 4 weeks, up to 16 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowloon Hospital, Hong Kong

Collaborators

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Marko Chan, PhDCandidate, Community Rehabilitation Service Supoort Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KowloonH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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