Stroke Clinical Trial
Official title:
The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke
Verified date | March 2024 |
Source | Kowloon Hospital, Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Community Rehabilitation Service Support Centre | Kowloon |
Lead Sponsor | Collaborator |
---|---|
Kowloon Hospital, Hong Kong | Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change score in Functional Independence Measure (FIM) from baseline | 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. | One day before the treatment , up to 4 weeks, up to 16 weeks | |
Secondary | 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. | One day before the treatment , up to 4 weeks, up to 16 weeks |
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