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
|Condition or disease||Intervention/treatment||Phase|
|Stroke Cognitive Impairment||Device: tDCS & neurofeedback Device: neurofeedback Device: sham neurofeedback||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Experimental: tDCS & neurofeedback
30 minutes tDCS & 30 minutes neurofeedback
Device: tDCS & neurofeedback
tDCs and neurofeedback
Active Comparator: real neurofeedback
30 minutes real neurofeedback.
Sham Comparator: sham neurofeedback
30 minutes sham neurofeedback.
Device: sham neurofeedback
- 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.
- 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.
- 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.
- 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.
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
|Contact: Marko Chan, MSc.||firstname.lastname@example.org|
|Kowloon, Hong Kong|
|Contact: Marko Chan, MSc. 852-31297131 email@example.com|
|Principal Investigator:||Marko Chan, MSc.||Kowloon Hospital|