StrokeNCT06307834
Restoring Grasp Ability in Stroke Survivors Through MI-Based Training
A study testing Neurofeedback - based therapy and Standard hand exercise therapy in people with Stroke, run by North Carolina State University at 1 site in United States.
Trial summary
Stroke is a leading cause of disability. Most stroke survivors face challenge in using their arm and hand to carry out daily task, such as grasping or holding objects. This issue makes it tough for nearly 65% of stroke survivors to return to work and take care of themselves. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Neurofeedback - based therapy and Standard hand exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 31 Dec 2025
- 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
- Age between 18 - 80 years
- Stroke-induced hand disability in one hand
- Experienced first stroke at least 6-month prior
- Difficulty in opening the hand \& grasping objects (Stage of Hand 4 or 5 on the Chedoke-McMaster Stroke Assessment (CMSA))
- Ability to distinguish specific shapes and colors on a computer screen
Who cannot join
- Inability to provide informed consent
- Suffering from severe pain in the shoulder or hand
- Having rigid contractures in the joints of the upper limbs, or orthopedic issues that prevent joint movement
- Presence of non-stroke neurological diseases
- Presence of severe cognitive deficits, such as unilateral spatial neglect or aphasia
- Experience of hand disability due to reasons other than stroke
- Having other serious medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Hand Rehabilitation Lab
Raleigh, North Carolina, 27695
Rinku Roy, PhD, 212-731-4114, rroy2@ncsu.edu
Derek G Kamper, PhD, 9195154411, dgkamper@ncsu.edu
About this study
Official title: Restoring Grasp Ability in Stroke Survivors Through Motor Imagery-Based Training With EEG Feedback
Stroke is a leading cause of disability. Most stroke survivors face challenge in using their arm and hand to carry out daily task, such as grasping or holding objects. This issue makes it tough for nearly 65% of stroke survivors to return to work and take care of themselves. The cause of their disability is changes in their brain's activity patterns of the motor cortex area. Traditional therapy does not directly alter these brain changes, which makes it less effective. As a way to help stroke survivors, people are looking into ways to train the brain directly. A method they found is motor imagery, which involves mental practicing of a task. Studies suggest that this type of training can potentially alter the brain's patterns, which can be seen through EEG. An EEG shows a fixed pattern during movement, called SMR (sensory motor rhythm). Studies have found that people can learn to control this SMR through mental practice of a task. The SMR changes in a similar way during both movement and motor imagery. Therefore, mental practice of hand tasks can lead to improvement in actual hand movements. It has already been shown that stroke survivors can open their hands more easily after receiving SMR training. Along with that, they also have trouble to hold and release objects. SMR training may be able to address these issues by changing brain patterns. But it is not clear yet if SMR training can improve all three stages of grasping (open, close, release), and to what extent it can enhance overall hand function.
This study plans to include 20 adults who have experienced a stroke and have ongoing problems with moving their hands. Half of these participants will take part in a training in which they will learn to control their SMR for three distinct hand tasks (open, close, and release). The first session will be followed by eight training sessions. To guide users toward specific changes in EEG activity, we will provide visual feedback in training. As soon as an appropriate EEG change is made, a hand exoskeleton will help them open and close their hand. The other group of 10 patients will have traditional therapy. They will do 9 sessions of hand exercises. During and after the training, we will test both groups to see how well their hand function improved. The result will help us determine which training method is better for stroke survivors.
- Conditions
- Stroke
- Being tested
- Neurofeedback - based therapy, Standard hand exercise therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback - based therapyBehavioural
This intervention will include mental practice of various hand movements accompanied by guided visual feedback, aimed at regulating brain activation patterns to facilitate the restoration of hand movements. We will also incorporate EMG signals to control a hand exoskeleton.
Standard hand exercise therapyBehavioural
This intervention will include engaging in a set of particular hand exercises with the aim of enhancing hand movements.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback - based therapy group | Experimental | In this arm/group, each participant will undergo a series of ten sessions (2-3 sessions per week) over a period of 3-5 weeks. Participants will be trained in modulating their brain activation patterns by using Mental Imagery (MI) involving various hand movements. EEG will be used to record brain responses. A visual feedback will be provided during the training to help achieve specific changes in brain responses. Once an appropriate brain response is achieved, an EMG-controlled hand exoskeleton will aid in opening and closing the hand. Receives: Behavioral: Neurofeedback - based therapy |
| Standard Hand exercises therapy group | Active comparator | In this arm/group, each participant will undergo a series of ten sessions (2-3 sessions per week) over a period of 3-5 weeks. At each session, participants will practice a particular set of hand exercises. In this intervention, a variety of games, tasks, and movements will be used to improve grasping abilities. These exercises will be personalized according to each participant's interests, which will be identified through the Canadian Occupational Performance Measure and will be guided by study personnel. Receives: Behavioral: Standard hand exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Box & Block test (BBT)
A quick, simple and inexpensive test used to assess and monitor unilateral gross manual dexterity
Measured: Change of value from before the intervention to immediately after the intervention
Change of Action Research Arm Test (ARAT)
A standardized measure used to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Measured: Change of value from before the intervention to immediately after the intervention
Change of Wolf Motor Function Test (WMFT)
A standardized, quantitative assessment used to assess upper extremity (UE) motor ability through timed and functional tasks
Measured: Change of value from before the intervention to immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Kamper, North Carolina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307834
- Sponsor's protocol ID
- 26760
- Other IDs
- 24POST1194772
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the specifications and limitations outlined by the Institutional Review Boards at North Carolina State University and the University of North Carolina at Chapel Hill, behavioral and performance data will be made available to other investigators upon request.
Publications
Norman SL, McFarland DJ, Miner A, Cramer SC, Wolbrecht ET, Wolpaw JR, Reinkensmeyer DJ. Controlling pre-movement sensorimotor rhythm can improve finger extension after stroke. J Neural Eng. 2018 Oct;15(5):056026. doi: 10.1088/1741-2552/aad724. Epub 2018 Jul 31.
PubMed 30063219Ono T, Shindo K, Kawashima K, Ota N, Ito M, Ota T, Mukaino M, Fujiwara T, Kimura A, Liu M, Ushiba J. Brain-computer interface with somatosensory feedback improves functional recovery from severe hemiplegia due to chronic stroke. Front Neuroeng. 2014 Jul 7;7:19. doi: 10.3389/fneng.2014.00019. eCollection 2014.
PubMed 25071543Foong R, Ang KK, Quek C, Guan C, Phua KS, Kuah CWK, Deshmukh VA, Yam LHL, Rajeswaran DK, Tang N, Chew E, Chua KSG. Assessment of the Efficacy of EEG-Based MI-BCI With Visual Feedback and EEG Correlates of Mental Fatigue for Upper-Limb Stroke Rehabilitation. IEEE Trans Biomed Eng. 2020 Mar;67(3):786-795. doi: 10.1109/TBME.2019.2921198. Epub 2019 Jun 5.
PubMed 31180829Seo NJ, Rymer WZ, Kamper DG. Delays in grip initiation and termination in persons with stroke: effects of arm support and active muscle stretch exercise. J Neurophysiol. 2009 Jun;101(6):3108-15. doi: 10.1152/jn.91108.2008. Epub 2009 Apr 8.
PubMed 19357330
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Grasp Ability in Stroke Survivors Through Motor Imagery-Based Training With EEG Feedback
- ClinicalTrials.gov ID
- NCT06307834
- Acronym / sponsor ID
- 26760
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Mar 2024 (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.
Stroke is a leading cause of disability. Most stroke survivors face challenge in using their arm and hand to carry out daily task, such as grasping or holding objects. This issue makes it tough for nearly 65% of stroke survivors to return to work and take care of themselves. The cause of their disability is changes in their brain's activity patterns of the motor cortex area. Traditional therapy does not directly alter these brain changes, which makes it less effective. As a way to help stroke survivors, people are looking into ways to train the brain directly. A method they found is motor imagery, which involves mental practicing of a task. Studies suggest that this type of training can potentially alter the brain's patterns, which can be seen through EEG. An EEG shows a fixed pattern during movement, called SMR (sensory motor rhythm). Studies have found that people can learn to control this SMR through mental practice of a task. The SMR changes in a similar way during both movement and motor imagery. Therefore, mental practice of hand tasks can lead to improvement in actual hand movements. It has already been shown that stroke survivors can open their hands more easily after receiving SMR training. Along with that, they also have trouble to hold and release objects. SMR training may be able to address these issues by changing brain patterns. But it is not clear yet if SMR training can improve all three stages of grasping (open, close, release), and to what extent it can enhance overall hand function.
This study plans to include 20 adults who have experienced a stroke and have ongoing problems with moving their hands. Half of these participants will take part in a training in which they will learn to control their SMR for three distinct hand tasks (open, close, and release). The first session will be followed by eight training sessions. To guide users toward specific changes in EEG activity, we will provide visual feedback in training. As soon as an appropriate EEG change is made, a hand exoskeleton will help them open and close their hand. The other group of 10 patients will have traditional therapy. They will do 9 sessions of hand exercises. During and after the training, we will test both groups to see how well their hand function improved. The result will help us determine which training method is better for stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback - based therapy group | Experimental | Behavioral: Neurofeedback - based therapyIn this arm/group, each participant will undergo a series of ten sessions (2-3 sessions per week) over a period of 3-5 weeks. Participants will be trained in modulating their brain activation patterns by using Mental Imagery (MI) involving various hand movements. EEG will be used to record brain responses. A visual feedback will be provided during the training to help achieve specific changes in brain responses. Once an appropriate brain response is achieved, an EMG-controlled hand exoskeleton will aid in opening and closing the hand. |
| Standard Hand exercises therapy group | Active comparator | Behavioral: Standard hand exercise therapyIn this arm/group, each participant will undergo a series of ten sessions (2-3 sessions per week) over a period of 3-5 weeks. At each session, participants will practice a particular set of hand exercises. In this intervention, a variety of games, tasks, and movements will be used to improve grasping abilities. These exercises will be personalized according to each participant's interests, which will be identified through the Canadian Occupational Performance Measure and will be guided by study personnel. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 - 80 years
- Stroke-induced hand disability in one hand
- Experienced first stroke at least 6-month prior
- Difficulty in opening the hand \& grasping objects (Stage of Hand 4 or 5 on the Chedoke-McMaster Stroke Assessment (CMSA))
- Ability to distinguish specific shapes and colors on a computer screen
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- Suffering from severe pain in the shoulder or hand
- Having rigid contractures in the joints of the upper limbs, or orthopedic issues that prevent joint movement
- Presence of non-stroke neurological diseases
- Presence of severe cognitive deficits, such as unilateral spatial neglect or aphasia
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 |
|---|---|---|
| Neurofeedback - based therapyThis intervention will include mental practice of various hand movements accompanied by guided visual feedback, aimed at regulating brain activation patterns to facilitate the restoration of hand movements. We will also incorporate EMG signals to control a hand exoskeleton. | Behavioural | Neurofeedback - based therapy group |
| Standard hand exercise therapyThis intervention will include engaging in a set of particular hand exercises with the aim of enhancing hand movements. | Behavioural | Standard Hand exercises therapy group |
Primary outcome
Change of Box & Block test (BBT)
Time frame: Change of value from before the intervention to immediately after the intervention
A quick, simple and inexpensive test used to assess and monitor unilateral gross manual dexterity
Change of Action Research Arm Test (ARAT)
Time frame: Change of value from before the intervention to immediately after the intervention
A standardized measure used to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Change of Wolf Motor Function Test (WMFT)
Time frame: Change of value from before the intervention to immediately after the intervention
A standardized, quantitative assessment used to assess upper extremity (UE) motor ability through timed and functional tasks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 30063219Norman SL, McFarland DJ, Miner A, Cramer SC, Wolbrecht ET, Wolpaw JR, Reinkensmeyer DJ. Controlling pre-movement sensorimotor rhythm can improve finger extension after stroke. J Neural Eng. 2018 Oct;15(5):056026. doi: 10.1088/1741-2552/aad724. Epub 2018 Jul 31.
- Background: PubMed 25071543Ono T, Shindo K, Kawashima K, Ota N, Ito M, Ota T, Mukaino M, Fujiwara T, Kimura A, Liu M, Ushiba J. Brain-computer interface with somatosensory feedback improves functional recovery from severe hemiplegia due to chronic stroke. Front Neuroeng. 2014 Jul 7;7:19. doi: 10.3389/fneng.2014.00019. eCollection 2014.
- Background: PubMed 31180829Foong R, Ang KK, Quek C, Guan C, Phua KS, Kuah CWK, Deshmukh VA, Yam LHL, Rajeswaran DK, Tang N, Chew E, Chua KSG. Assessment of the Efficacy of EEG-Based MI-BCI With Visual Feedback and EEG Correlates of Mental Fatigue for Upper-Limb Stroke Rehabilitation. IEEE Trans Biomed Eng. 2020 Mar;67(3):786-795. doi: 10.1109/TBME.2019.2921198. Epub 2019 Jun 5.
- Background: PubMed 19357330Seo NJ, Rymer WZ, Kamper DG. Delays in grip initiation and termination in persons with stroke: effects of arm support and active muscle stretch exercise. J Neurophysiol. 2009 Jun;101(6):3108-15. doi: 10.1152/jn.91108.2008. Epub 2009 Apr 8.
- Individual participant dataSharing planned: Yes. In accordance with the specifications and limitations outlined by the Institutional Review Boards at North Carolina State University and the University of North Carolina at Chapel Hill, behavioral and performance data will be made available to other investigators upon request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback - based therapy and Standard hand exercise therapy in people with Stroke, run by North Carolina State University at 1 site in United States.
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 5 inclusion and 7 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 13 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 United States. 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 Derek G Kamper, PhD (7735201233, dgkamper@ncsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Box & Block test (BBT) (time frame: Change of value from before the intervention to immediately after the intervention). The study lists 3 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 NCT06307834, 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 13 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.