Clinical trial NCT06307834: Restoring Grasp Ability in Stroke Survivors Through MI-Based Training
Official title: Restoring Grasp Ability in Stroke Survivors Through Motor Imagery-Based Training With EEG Feedback
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: North Carolina State University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 - 80 years
2. Stroke-induced hand disability in one hand
3. Experienced first stroke at least 6-month prior
4. Difficulty in opening the hand \& grasping objects (Stage of Hand 4 or 5 on the Chedoke-McMaster Stroke Assessment (CMSA))
5. Ability to distinguish specific shapes and colors on a computer screen

Exclusion Criteria:

1. Inability to provide informed consent
2. Suffering from severe pain in the shoulder or hand
3. Having rigid contractures in the joints of the upper limbs, or orthopedic issues that prevent joint movement
4. Presence of non-stroke neurological diseases
5. Presence of severe cognitive deficits, such as unilateral spatial neglect or aphasia
6. Experience of hand disability due to reasons other than stroke
7. Having other serious medical conditions

Primary outcomes:
measure: Change of Box & Block test (BBT)
timeFrame: Change of value from before the intervention to immediately after the intervention
measure: Change of Action Research Arm Test (ARAT)
timeFrame: Change of value from before the intervention to immediately after the intervention
measure: Change of Wolf Motor Function Test (WMFT)
timeFrame: Change of value from before the intervention to immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Hand Rehabilitation Lab
state: North Carolina
Study officials:
References:
citation: 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.
citation: Ono 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.
citation: Foong 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.
citation: Seo 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.