StrokeNCT04944680
Dual Channel Rehabilitation Technology Promotes Rapid Recovery of Upper Limbs After Stroke
A study testing Transcranial Direct Current Stimulation therapy, Motor imagery therapy and Transcranial Direct Current Stimulation and motor imagery therapy in people with Stroke and Upper Extremity Dysfunction, run by Fu Xing Hospital, Capital Medical University at 1 site in China.
Trial summary
The injury and remodeling mechanism about upper extremity motor network after stroke is not clear. There are few studies on the motor network covering cortex, white matter and blood perfusion at the time. Some studies have shown that metal imagery activates the cortex through active mental simulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Upper Extremity Dysfunction, Transcranial Direct Current Stimulation
- What is being tested?
- Transcranial Direct Current Stimulation therapy, Motor imagery therapy and Transcranial Direct Current Stimulation and motor imagery therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2021to Jun 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke with upper limb motor dysfunction
- No rapid natural recovery in the last week
- Greater than 1 month since stroke onset
- Pass the motor imagery test
Who cannot join
- Severe cognitive disorder
- Severe spasm or joint contracture
- Mental implants in vivo
- Do not sign the informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fu Xing Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Ran Li, Doctor, +86-010-88062907, liran817@sina.com
About this study
Official title: Effects of Transcranial Direct Current Stimulation and Motor Imagery for the Recovery of Upper Limb Function of Stroke Patients
The injury and remodeling mechanism about upper extremity motor network after stroke is not clear. There are few studies on the motor network covering cortex, white matter and blood perfusion at the time. Some studies have shown that metal imagery activates the cortex through active mental simulation. Our previous study has shown that passive application of transcranial direct current stimulation causes subthreshold polarization and promotes the effective integration of residual brain high-level network. This study proposes a hypothesis: transcranial Direct Current Stimulation + Motor Imagery combines active and passive neuromodulation techniques to produce dual channel effect, which can synergistically excite motor cortex, remodel the motor network and optimize cerebral perfusion. The research contents include clarify the effect of transcranial Direct Current Stimulation + Motor Imagery neuromodulation therapy through comprehensive randomized controlled trial study; present the process of brain injury and secondary neural plasticity through the motor network construction, functional connectivity strength and cerebral perfusion with Blood Oxygen Level Dependent, Diffusion Tensor Imaging and Arterial Spin Labeling multimodal magnetic resonance technology; calculate the correlation between motor score and brain functional network, extract the key nodes that can promote the motor network remodeling. The research results are expected to provide preliminary theoretical foundations for further research on the injury and remodeling mechanism about upper extremity motor network after stroke.
- Being tested
- Transcranial Direct Current Stimulation therapy, Motor imagery therapy, Transcranial Direct Current Stimulation and motor imagery therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation therapyBehavioural
Transcranial Direct Current Stimulation with two saline-soaked electrodes (5cm x 7cm) is applied by our occupational therapist. The anode is placed on the ipsilesional primary motor cortex (C3/C4). The cathode is placed on the contralesional shoulder. The current is 1.5 milliampere and lasts 20 minutes.
Motor imagery therapyBehavioural
Stroke patients are asked to watch a video about the upper extremity movement. The video lasts 20 minutes. The contents are as follows: the patients are asked to relax the muscles for the first 2 minutes; the action refers to shoulder flexion and extension, elbow flexion and extension, forearm pronation and supination, wrist flexion and extension, finger flexion and extension, and corresponding daily functional activities for 16min; the patients are asked to relax their mind and body for the last 2 minutes.
Transcranial Direct Current Stimulation and motor imagery therapyBehavioural
The treatment parameters are the same as the above. It should be emphasized that the participants sit and perform the motor imagery task while receiving Transcranial Direct Current Stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Stroke patients accept the traditional rehabilitation alone. |
| Transcranial Direct Current Stimulation group | Active comparator | Stroke patients accept the Transcranial Direct Current Stimulation alone. Receives: Behavioral: Transcranial Direct Current Stimulation therapy |
| Motor imagery group | Active comparator | Stroke patients do the motor imagery alone. Receives: Behavioral: Motor imagery therapy |
| Transcranial Direct Current Stimulation and motor imagery group | Experimental | Stroke patients accept the Transcranial Direct Current Stimulation and do the motor imagery at the same time. Receives: Behavioral: Transcranial Direct Current Stimulation and motor imagery therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb
Complete the scale at baseline
Measured: Baseline
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb change
Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Fugl-Meyer Assessment score.
Measured: Immediately after intervention
Behavioral assessment by Action Research Arm Test
Complete the above scale at baseline
Measured: Baseline
Behavioral assessment by Action Research Arm Test change
Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Action Research Arm Test score.
Measured: Immediately after intervention
Motor network construction
Construct the motor network with the bilateral primary motor cortices, supplementary motor cortices, premotor cortices, thalami and cerebellums et al. as the nodes of the network. Motor network analysis consists the network strength, global efficiency and local efficiency. The software used is PANDA and GRETNA.
Measured: Baseline
Motor network change
Change from baseline motor network immediately after intervention is obtained by subtracting the baseline from the later network strength, global efficiency and local efficiency.
Measured: Immediately after intervention
Cerebral perfusion calculation
The volume of interest covers the motor related territory including bilateral primary motor cortices, supplementary motor cortices, premotor cortices, thalami and cerebellums et al. The mean Cerebral Blood Flow value is calculated. The software used is Function Tool.
Measured: Baseline
Cerebral perfusion change
Change from baseline cerebral perfusion immediately after intervention is obtained by subtracting the baseline from the later Cerebral Blood Flow value.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start9 Jun 2021
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Model description
- The four parallel groups are as follows: control group, Transcranial Direct Current Stimulation group, motor imagery group, Transcranial Direct Current Stimulation and motor imagery group. Patients are randomly assigned to each group with block randomization.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xing Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ran Li, Fu Xing Hospital, Capital Medical University
- Investigators
- Lirong Huo, Doctor, Study director, Office of academic research, Fu Xing Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944680
- Sponsor's protocol ID
- 2021FXHEC-KSKY002
- Status last verified
- Aug 2022
- First submitted
- 12 Jun 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marquez JL, Conley AC, Karayanidis F, Miller J, Lagopoulos J, Parsons MW. Determining the benefits of transcranial direct current stimulation on functional upper limb movement in chronic stroke. Int J Rehabil Res. 2017 Jun;40(2):138-145. doi: 10.1097/MRR.0000000000000220.
PubMed 28196011Kaneko F, Shibata E, Hayami T, Nagahata K, Aoyama T. The association of motor imagery and kinesthetic illusion prolongs the effect of transcranial direct current stimulation on corticospinal tract excitability. J Neuroeng Rehabil. 2016 Apr 15;13:36. doi: 10.1186/s12984-016-0143-8.
PubMed 27079199Lioi G, Butet S, Fleury M, Bannier E, Lecuyer A, Bonan I, Barillot C. A Multi-Target Motor Imagery Training Using Bimodal EEG-fMRI Neurofeedback: A Pilot Study in Chronic Stroke Patients. Front Hum Neurosci. 2020 Feb 18;14:37. doi: 10.3389/fnhum.2020.00037. eCollection 2020.
PubMed 32132910Lee J, Lee A, Kim H, Shin M, Yun SM, Jung Y, Chang WH, Kim YH. Different Brain Connectivity between Responders and Nonresponders to Dual-Mode Noninvasive Brain Stimulation over Bilateral Primary Motor Cortices in Stroke Patients. Neural Plast. 2019 Apr 7;2019:3826495. doi: 10.1155/2019/3826495. eCollection 2019.
PubMed 31093270
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation and Motor Imagery for the Recovery of Upper Limb Function of Stroke Patients
- ClinicalTrials.gov ID
- NCT04944680
- Acronym / sponsor ID
- 2021FXHEC-KSKY002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 29 Jun 2021 (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.
The injury and remodeling mechanism about upper extremity motor network after stroke is not clear. There are few studies on the motor network covering cortex, white matter and blood perfusion at the time. Some studies have shown that metal imagery activates the cortex through active mental simulation. Our previous study has shown that passive application of transcranial direct current stimulation causes subthreshold polarization and promotes the effective integration of residual brain high-level network. This study proposes a hypothesis: transcranial Direct Current Stimulation + Motor Imagery combines active and passive neuromodulation techniques to produce dual channel effect, which can synergistically excite motor cortex, remodel the motor network and optimize cerebral perfusion. The research contents include clarify the effect of transcranial Direct Current Stimulation + Motor Imagery neuromodulation therapy through comprehensive randomized controlled trial study; present the process of brain injury and secondary neural plasticity through the motor network construction, functional connectivity strength and cerebral perfusion with Blood Oxygen Level Dependent, Diffusion Tensor Imaging and Arterial Spin Labeling multimodal magnetic resonance technology; calculate the correlation between motor score and brain functional network, extract the key nodes that can promote the motor network remodeling. The research results are expected to provide preliminary theoretical foundations for further research on the injury and remodeling mechanism about upper extremity motor network after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- The four parallel groups are as follows: control group, Transcranial Direct Current Stimulation group, motor imagery group, Transcranial Direct Current Stimulation and motor imagery group. Patients are randomly assigned to each group with block randomization.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Stroke patients accept the traditional rehabilitation alone. |
| Transcranial Direct Current Stimulation group | Active comparator | Behavioral: Transcranial Direct Current Stimulation therapyStroke patients accept the Transcranial Direct Current Stimulation alone. |
| Motor imagery group | Active comparator | Behavioral: Motor imagery therapyStroke patients do the motor imagery alone. |
| Transcranial Direct Current Stimulation and motor imagery group | Experimental | Behavioral: Transcranial Direct Current Stimulation and motor imagery therapyStroke patients accept the Transcranial Direct Current Stimulation and do the motor imagery at the same time. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First stroke with upper limb motor dysfunction
- No rapid natural recovery in the last week
- Greater than 1 month since stroke onset
- Pass the motor imagery test
Key exclusion criteria (4 listed)
- Severe cognitive disorder
- Severe spasm or joint contracture
- Mental implants in vivo
- Do not sign the informed consent
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 |
|---|---|---|
| Transcranial Direct Current Stimulation therapyTranscranial Direct Current Stimulation with two saline-soaked electrodes (5cm x 7cm) is applied by our occupational therapist. The anode is placed on the ipsilesional primary motor cortex (C3/C4). The cathode is placed on the contralesional shoulder. The current is 1.5 milliampere and lasts 20 minutes. | Behavioural | Transcranial Direct Current Stimulation group |
| Motor imagery therapyStroke patients are asked to watch a video about the upper extremity movement. The video lasts 20 minutes. The contents are as follows: the patients are asked to relax the muscles for the first 2 minutes; the action refers to shoulder flexion and extension, elbow flexion and extension, forearm pronation and supination, wrist flexion and extension, finger flexion and extension, and corresponding daily functional activities for 16min; the patients are asked to relax their mind and body for the last 2 minutes. | Behavioural | Motor imagery group |
| Transcranial Direct Current Stimulation and motor imagery therapyThe treatment parameters are the same as the above. It should be emphasized that the participants sit and perform the motor imagery task while receiving Transcranial Direct Current Stimulation. | Behavioural | Transcranial Direct Current Stimulation and motor imagery group |
Primary outcome
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb
Time frame: Baseline
Complete the scale at baseline
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb change
Time frame: Immediately after intervention
Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Fugl-Meyer Assessment score.
Behavioral assessment by Action Research Arm Test
Time frame: Baseline
Complete the above scale at baseline
Behavioral assessment by Action Research Arm Test change
Time frame: Immediately after intervention
Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Action Research Arm Test score.
Motor network construction
Time frame: Baseline
Construct the motor network with the bilateral primary motor cortices, supplementary motor cortices, premotor cortices, thalami and cerebellums et al. as the nodes of the network. Motor network analysis consists the network strength, global efficiency and local efficiency. The software used is PANDA and GRETNA.
Motor network change
Time frame: Immediately after intervention
Change from baseline motor network immediately after intervention is obtained by subtracting the baseline from the later network strength, global efficiency and local efficiency.
Cerebral perfusion calculation
Time frame: Baseline
The volume of interest covers the motor related territory including bilateral primary motor cortices, supplementary motor cortices, premotor cortices, thalami and cerebellums et al. The mean Cerebral Blood Flow value is calculated. The software used is Function Tool.
Cerebral perfusion change
Time frame: Immediately after intervention
Change from baseline cerebral perfusion immediately after intervention is obtained by subtracting the baseline from the later Cerebral Blood Flow value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 28196011Marquez JL, Conley AC, Karayanidis F, Miller J, Lagopoulos J, Parsons MW. Determining the benefits of transcranial direct current stimulation on functional upper limb movement in chronic stroke. Int J Rehabil Res. 2017 Jun;40(2):138-145. doi: 10.1097/MRR.0000000000000220.
- Background: PubMed 27079199Kaneko F, Shibata E, Hayami T, Nagahata K, Aoyama T. The association of motor imagery and kinesthetic illusion prolongs the effect of transcranial direct current stimulation on corticospinal tract excitability. J Neuroeng Rehabil. 2016 Apr 15;13:36. doi: 10.1186/s12984-016-0143-8.
- Background: PubMed 32132910Lioi G, Butet S, Fleury M, Bannier E, Lecuyer A, Bonan I, Barillot C. A Multi-Target Motor Imagery Training Using Bimodal EEG-fMRI Neurofeedback: A Pilot Study in Chronic Stroke Patients. Front Hum Neurosci. 2020 Feb 18;14:37. doi: 10.3389/fnhum.2020.00037. eCollection 2020.
- Background: PubMed 31093270Lee J, Lee A, Kim H, Shin M, Yun SM, Jung Y, Chang WH, Kim YH. Different Brain Connectivity between Responders and Nonresponders to Dual-Mode Noninvasive Brain Stimulation over Bilateral Primary Motor Cortices in Stroke Patients. Neural Plast. 2019 Apr 7;2019:3826495. doi: 10.1155/2019/3826495. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Lirong Huo, Doctor study director
Office of academic research, Fu Xing Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation therapy, Motor imagery therapy and Transcranial Direct Current Stimulation and motor imagery therapy in people with Stroke and Upper Extremity Dysfunction, run by Fu Xing Hospital, Capital Medical University at 1 site 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 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: status not confirmed, as of the sponsor's last update on 4 Aug 2022. 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 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. 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 Ran Li, Doctor (+86-010-88062907, liran817@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04944680, which also lists 4 linked publications.
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 4 Aug 2022.