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

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ClinicalTrials.gov Identifier: NCT03093142
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Marko Chan, Kowloon Hospital, Hong Kong

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.

Condition or disease Intervention/treatment Phase
Stroke Cognitive Impairment Device: tDCS & neurofeedback Device: neurofeedback Device: sham neurofeedback Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Change score in Executive function performance Test (EFPT) from baseline [ Time Frame: One day before the treatment , up to 4 weeks, up to 16 weeks ]
    The Executive Function Performance Test is a performance-based assessment of executive function through observation of four Instrumental Activities of Daily Living.

  2. Change score in Functional Independence Measure (FIM) from basline [ 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093142


Contacts
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Contact: Marko Chan, MSc. 31297131 ckl892@ha.org.hk

Locations
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Hong Kong
Kowloon Hospital Recruiting
Kowloon, Hong Kong
Contact: Marko Chan, MSc.    852-31297131    ckl892@ha.org.hk   
Sponsors and Collaborators
Kowloon Hospital, Hong Kong
Chinese University of Hong Kong
Investigators
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Principal Investigator: Marko Chan, MSc. Kowloon Hospital

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Responsible Party: Marko Chan, Principal Investigator, Kowloon Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT03093142     History of Changes
Other Study ID Numbers: KowloonH
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marko Chan, Kowloon Hospital, Hong Kong:
transcranial direct current stimulation (tDCs)
neurofeedback

Additional relevant MeSH terms:
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Stroke
Cognitive Dysfunction
Cognition Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders