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

NCT03093142 | Completed DMC

• 1 other identifier: KowloonH
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cognitive Impairment

Keywords

transcranial direct current stimulation (tDCs); neurofeedback

Outcome Measures

Primary Outcomes (1)

• 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.

  One day before the treatment , up to 4 weeks, up to 16 weeks

Secondary Outcomes (2)

• 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 Arms (3)

tDCS & neurofeedback

EXPERIMENTAL

30 minutes tDCS \& 30 minutes neurofeedback

Device: tDCS & neurofeedback

real neurofeedback

ACTIVE COMPARATOR

30 minutes real neurofeedback.

Device: neurofeedback

sham neurofeedback

SHAM COMPARATOR

30 minutes sham neurofeedback.

Device: sham neurofeedback

Interventions

tDCS & neurofeedback DEVICE

tDCs and neurofeedback

tDCS & neurofeedback

neurofeedback DEVICE

Neurofeedback

real neurofeedback

sham neurofeedback DEVICE

sham neurofeedback

sham neurofeedback

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kowloon Hospital, Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Community Rehabilitation Service Support Centre

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation; Neurofeedback

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Feedback, Psychological

Study Officials

• Marko Chan, PhDCandidate

  Community Rehabilitation Service Supoort Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 28, 2017
• Study Start: March 1, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)