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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093142
• Other study ID #: KowloonH
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2024
• Source: Kowloon Hospital, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Cognitive Impairment
• Stroke

Intervention

Device:
• tDCS & neurofeedback
tDCs and neurofeedback
• neurofeedback
Neurofeedback
• sham neurofeedback
sham neurofeedback

Locations

Country	Name	City	State
Hong Kong	Community Rehabilitation Service Support Centre	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
Kowloon Hospital, Hong Kong	Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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