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Completed

NCT Number: NCT03093142

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Nervous System Diseases Neurocognitive Disorders Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Rehabilitation Service Support Centre

Kowloon, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tDCS & neurofeedback

Device

tDCs and neurofeedback

Neurofeedback

Device

Neurofeedback

Sham neurofeedback

Device

sham neurofeedback

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Kowloon Hospital, Hong Kong

Other

Collaborators

  • Chinese University of Hong Kong

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 28, 2017
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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