StrokeNCT03093142
The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke
A study testing tDCS & neurofeedback and neurofeedback in people with Stroke and Cognitive Impairment, run by Kowloon Hospital, Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Cognitive Impairment
- What is being tested?
- tDCS & neurofeedback and neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke, Cognitive Impairment
- Being tested
- tDCS & neurofeedback, neurofeedback, sham neurofeedback
- Keywords
- transcranial direct current stimulation (tDCs), neurofeedback
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS & neurofeedbackDevice
tDCs and neurofeedback
neurofeedbackDevice
Neurofeedback
sham neurofeedbackDevice
sham neurofeedback
| Study group | Role | What they receive |
|---|---|---|
| tDCS & neurofeedback | Experimental | 30 minutes tDCS \& 30 minutes neurofeedback Receives: Device: tDCS & neurofeedback |
| real neurofeedback | Active comparator | 30 minutes real neurofeedback. Receives: Device: neurofeedback |
| sham neurofeedback | Sham comparator | 30 minutes sham neurofeedback. Receives: Device: sham neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day before the treatment , up to 4 weeks, up to 16 weeks
Secondary outcomes (2)
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.
Measured: One day before the treatment , up to 4 weeks, up to 16 weeks
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.
Measured: One day before the treatment , up to 4 weeks, up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 Mar 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowloon Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Marko Chan, Kowloon Hospital, Hong Kong
- Investigators
- Marko Chan, PhDCandidate, Principal investigator, Community Rehabilitation Service Supoort Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093142
- Sponsor's protocol ID
- KowloonH
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2017
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment Effectiveness of Combined tDCs and Neurofeedback (NF) for Patients With Cognitive Deficits After Stroke
- ClinicalTrials.gov ID
- NCT03093142
- Acronym / sponsor ID
- KowloonH
- Conditions
- Stroke, Cognitive Impairment
- Keywords
- transcranial direct current stimulation (tDCs), neurofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kowloon Hospital, Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS & neurofeedback | Experimental | Device: tDCS & neurofeedback30 minutes tDCS \& 30 minutes neurofeedback |
| real neurofeedback | Active comparator | Device: neurofeedback30 minutes real neurofeedback. |
| sham neurofeedback | Sham comparator | Device: sham neurofeedback30 minutes sham neurofeedback. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS & neurofeedbacktDCs and neurofeedback | Device | tDCS & neurofeedback |
| neurofeedbackNeurofeedback | Device | real neurofeedback |
| sham neurofeedbacksham neurofeedback | Device | sham neurofeedback |
Primary outcome
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.
2 secondary outcomes
Change score in Functional Independence Measure (FIM) from baseline
Time frame: One day before the treatment , up to 4 weeks, up to 16 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Chan, PhDCandidate principal investigator
Community Rehabilitation Service Supoort Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS & neurofeedback and neurofeedback in people with Stroke and Cognitive Impairment, run by Kowloon Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.