search
Back to results

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

Primary Purpose

Stroke, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
tDCS & neurofeedback
neurofeedback
sham neurofeedback
Sponsored by
Kowloon Hospital, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring transcranial direct current stimulation (tDCs), neurofeedback

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Community Rehabilitation Service Support Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

tDCS & neurofeedback

real neurofeedback

sham neurofeedback

Arm Description

30 minutes tDCS & 30 minutes neurofeedback

30 minutes real neurofeedback.

30 minutes sham neurofeedback.

Outcomes

Primary Outcome Measures

Change score in Trail Making Test A & B from baseline
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 Outcome Measures

Change score in Executive function performance Test (EFPT) from baseline
The Executive Function Performance Test is a performance-based assessment of executive function through observation of four Instrumental Activities of Daily Living.
Change score in Functional Independence Measure (FIM) from basline
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.
Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA - SIP 30)
SA-SIP 30 assesses quality of life in patients who have sustained a stroke.

Full Information

First Posted
March 1, 2017
Last Updated
August 4, 2021
Sponsor
Kowloon Hospital, Hong Kong
Collaborators
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT03093142
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kowloon Hospital, Hong Kong
Collaborators
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cognitive Impairment
Keywords
transcranial direct current stimulation (tDCs), neurofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS & neurofeedback
Arm Type
Experimental
Arm Description
30 minutes tDCS & 30 minutes neurofeedback
Arm Title
real neurofeedback
Arm Type
Active Comparator
Arm Description
30 minutes real neurofeedback.
Arm Title
sham neurofeedback
Arm Type
Sham Comparator
Arm Description
30 minutes sham neurofeedback.
Intervention Type
Device
Intervention Name(s)
tDCS & neurofeedback
Intervention Description
tDCs and neurofeedback
Intervention Type
Device
Intervention Name(s)
neurofeedback
Intervention Description
Neurofeedback
Intervention Type
Device
Intervention Name(s)
sham neurofeedback
Intervention Description
sham neurofeedback
Primary Outcome Measure Information:
Title
Change score in Trail Making Test A & B from baseline
Description
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.
Time Frame
One day before the treatment , up to 4 weeks, up to 16 weeks
Secondary Outcome Measure Information:
Title
Change score in Executive function performance Test (EFPT) from baseline
Description
The Executive Function Performance Test is a performance-based assessment of executive function through observation of four Instrumental Activities of Daily Living.
Time Frame
One day before the treatment , up to 4 weeks, up to 16 weeks
Title
Change score in Functional Independence Measure (FIM) from basline
Description
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.
Time Frame
One day before the treatment , up to 4 weeks, up to 16 weeks
Title
Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA - SIP 30)
Description
SA-SIP 30 assesses quality of life in patients who have sustained a stroke.
Time Frame
One day before the treatment , up to 4 weeks, up to 16 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marko Chan, PhD Candidate
Organizational Affiliation
Community Rehabilitation Service Supoort Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Rehabilitation Service Support Centre
City
Kowloon
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs