Cognitive DysfunctionNCT04133714
A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
A study testing multi-channel tDCS and single-channel tDCS in people with Cognitive Dysfunction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites in China.
Trial summary
This clinical RCT study intends to combined different forms of multi-channel tDCS with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction. The therapeutic effects among single-channel tDCS group, multi-channel tDCS and pseudo-multichannel tDCS group will be compared. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- multi-channel tDCS and single-channel tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 4 sitesChina
- Study dates
- 1 Nov 2020to Dec 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 year-old
- diagnosed cerebral apoplexy, meeting the diagnostic criteria of ICD-10
- cognitive function, perceptual function decline after stroke
- first onset and duration of 3-12 months
- right-handed
- MMSE ≤25
- MoCA ≤25
- sign informed consent voluntarily and comply with the study plan
Who cannot join
- NIHSS ≥21 points
- MoCA ≤18, or DRS-2 ≤ 124, or CES-D ≥ 16
- taking drugs that affect central nervous activity, such as nerve antagonists
- specific contraindication, such as electrode patch allergy, local skin injury or - - - - inflammation, and hyperalgesia in stimulated areas
- patients use implantable electronic devices (such as cardiac pacemakers) or have - metal implants such as stents that affect MRI examination
- patients with a previous history of epilepsy, mental illness or skull injury
Show all 9Show fewer
- patients with dementia or obvious cognitive dysfunction before stroke
- patients with aphasia or dysarthria and cannot complete the scale evaluation
- pregnancy
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Southwest Hospital
Chongqing, 400000
Jingming Hou, Dr.
- Recruiting
Rainbowfish Rehabilitation Nursing Care
Hangzhou, Zhejiang, 310000
Ran Wang, Dr.
- Recruiting
SAHZhejiangU
Hangzhou, Zhejiang, 310009
Hongjie Jiang, Dr.
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Ruidong Cheng, Dr.
About this study
This clinical RCT study intends to combined different forms of multi-channel tDCS with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction.
The therapeutic effects among single-channel tDCS group, multi-channel tDCS and pseudo-multichannel tDCS group will be compared. Brain magnetic resonance mechanism research will also be included to reveal the possible mechanism of multi-channel tDCS technology for PSCI brain network.
Thus, the efficacy and mechanism of multi-channel tDCS in post-stroke cognitive function rehabilitation will be researched both in the clinical and basic levels.
- Conditions
- Cognitive Dysfunction
- Being tested
- multi-channel tDCS, single-channel tDCS
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-channel tDCSDevice
multi-channel transcranial direct current stimulation, tDCS
single-channel tDCSDevice
single-channel transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| multi-channel tDCS | Experimental | In the multi-channel tDCS stimulation group, a 1:4 (anode: cathode) approach was applied, with the central anode placed in the left dorsolateral prefrontal cortex (dlPFC) (reference 10-20 standard lead EEG), and the remaining cathode distributed around the central electrode.
The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). Receives: Device: multi-channel tDCS |
| single-channel tDCS | Experimental | The anode electrode of the single-channel tDCS stimulation group was placed in the left dlPFC, and the cathode electrode was placed in the right orbital forehead.
The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). Receives: Device: single-channel tDCS |
| sham stimulation | Sham comparator | The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation. Receives: Device: multi-channel tDCS; Device: single-channel tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
Mini-mental State Examination
Measured: Change from Baseline MMSE at 2 weeks and 3 months after intervention
MoCA
Montreal Cognitive Assessment
Measured: Change from Baseline MoCA at 2 weeks and 3 months after intervention
AVLT
The Auditory-Verbal Learning Test
Measured: Change from Baseline AVLT at 2 weeks and 3 months after intervention
WAIS-DST
WAIS Digit Symbol Test
Measured: Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
Secondary outcomes (2)
DEX
Dysexecutive Ques-tionnaire
Measured: Change from Baseline DEX at 2 weeks and 3 months after intervention
GNAT
Go/No-go Association Task
Measured: Change from Baseline GNAT at 2 weeks and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Nov 2020 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongjie Jiang, Dr., Study chair, Second Affiliated Hospital, Zhejiang University, School of MedicineRuidong Cheng, Dr., Principal investigator, Zhejiang Provincial People's HospitalRang Wang, Dr., Principal investigator, Rainbowfish Rehabilitation Nursing CareJingming Hou, Dr., Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133714
- Sponsor's protocol ID
- 2019-313
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 29 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
- ClinicalTrials.gov ID
- NCT04133714
- Acronym / sponsor ID
- 2019-313
- Conditions
- Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Oct 2019 (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 clinical RCT study intends to combined different forms of multi-channel tDCS with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction.
The therapeutic effects among single-channel tDCS group, multi-channel tDCS and pseudo-multichannel tDCS group will be compared. Brain magnetic resonance mechanism research will also be included to reveal the possible mechanism of multi-channel tDCS technology for PSCI brain network.
Thus, the efficacy and mechanism of multi-channel tDCS in post-stroke cognitive function rehabilitation will be researched both in the clinical and basic levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| multi-channel tDCS | Experimental | Device: multi-channel tDCSIn the multi-channel tDCS stimulation group, a 1:4 (anode: cathode) approach was applied, with the central anode placed in the left dorsolateral prefrontal cortex (dlPFC) (reference 10-20 standard lead EEG), and the remaining cathode distributed around the central electrode. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). |
| single-channel tDCS | Experimental | Device: single-channel tDCSThe anode electrode of the single-channel tDCS stimulation group was placed in the left dlPFC, and the cathode electrode was placed in the right orbital forehead. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). |
| sham stimulation | Sham comparator | Device: multi-channel tDCS, Device: single-channel tDCSThe shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-60 year-old
- diagnosed cerebral apoplexy, meeting the diagnostic criteria of ICD-10
- cognitive function, perceptual function decline after stroke
- first onset and duration of 3-12 months
- right-handed
Key exclusion criteria (9 listed)
- NIHSS ≥21 points
- MoCA ≤18, or DRS-2 ≤ 124, or CES-D ≥ 16
- taking drugs that affect central nervous activity, such as nerve antagonists
- specific contraindication, such as electrode patch allergy, local skin injury or - - - - inflammation, and hyperalgesia in stimulated areas
- patients use implantable electronic devices (such as cardiac pacemakers) or have - metal implants such as stents that affect MRI examination
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 |
|---|---|---|
| multi-channel tDCSmulti-channel transcranial direct current stimulation, tDCS | Device | multi-channel tDCS, sham stimulation |
| single-channel tDCSsingle-channel transcranial direct current stimulation | Device | sham stimulation, single-channel tDCS |
Primary outcome
MMSE
Time frame: Change from Baseline MMSE at 2 weeks and 3 months after intervention
Mini-mental State Examination
MoCA
Time frame: Change from Baseline MoCA at 2 weeks and 3 months after intervention
Montreal Cognitive Assessment
AVLT
Time frame: Change from Baseline AVLT at 2 weeks and 3 months after intervention
The Auditory-Verbal Learning Test
WAIS-DST
Time frame: Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
WAIS Digit Symbol Test
2 secondary outcomes
DEX
Time frame: Change from Baseline DEX at 2 weeks and 3 months after intervention
GNAT
Time frame: Change from Baseline GNAT at 2 weeks and 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
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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.
Hongjie Jiang, Dr. study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
Ruidong Cheng, Dr. principal investigator
Zhejiang Provincial People's Hospital
Rang Wang, Dr. principal investigator
Rainbowfish Rehabilitation Nursing Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-channel tDCS and single-channel tDCS in people with Cognitive Dysfunction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites in China.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongjie Jiang, Dr. (+86 13777830137, insjhj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (time frame: Change from Baseline MMSE at 2 weeks and 3 months after intervention). The study lists 4 primary outcomes in all. 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 29 Oct 2020.