Chronic stroke survivors suffering from weaknesses or movement difficulties in their hand/arm are provided a system to aid in at-home rehabilitation for 6 weeks. This rehabilitation system includes a headband that measures and provides feedback from the brain during rehabilitation, together with tablet-based software. Throughout the 6 week rehabilitation period (as well as in a follow-up session 1 month afterwards) several assessments are taken to understand the effect of this rehabilitation on participant's movement abilities, as well as their brain activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Rehabilitation system comprised of functional near-infrared spectroscopy headband (measuring from the motor cortex), as well as tablet-based software application (guiding stroke survivors through rehabilitation exercises for their hands/arms).
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDetermine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Some participants will demonstrate a pre- to post-test increase of 6 in the Fugl-Meyer Upper-Extremity subscale.
Time frame: 6 weeks
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Some participants will demonstrate a pre- to post-test increase of 12 in the Action Research Arm Test.
Time frame: 6 weeks
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Some participants will demonstrate a pre- to post-test increase of either 0.5 in the Motor Activity Log.
Time frame: 6 weeks
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
Some participants will demonstrate a pre- to post-test minimally clinically important differences the Stroke Impact Scale.
Time frame: 6 weeks
Determine when in the course of the study (if at all) fNIRS data contains predictive information regarding the likelihood that participants would respond to at-home BCI rehabilitation.
Significant differences between responders and non-responders (as defined in the endpoint of primary objective 1) in fNIRS measures taken either during pre-test fNIRS tasks or at-home BCI sessions which are not accounted for by pre-test FMA-UE assessment scores (see Statistical Methods below for more information).
Time frame: 6 weeks
Determine when in the course of the study (if at all) fNIRS data contains predictive information regarding the likelihood that participants would respond to at-home BCI rehabilitation.
Significant differences between responders and non-responders (as defined in the endpoint of primary objective 1) in fNIRS measures taken either during pre-test fNIRS tasks or at-home BCI sessions which are not accounted for by pre-test ARAT assessment scores (see Statistical Methods below for more information).
Time frame: 6 weeks
Determine whether participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device.
A significant difference between mean ∆HbO during either (1) the MI Task conducted at the pre-test period and MI during at-home BCI sessions conducted during week 5 and/or (2) the Motor Execution Task conducted at the pre-test ME Task and ME during at-home BCI sessions conducted during week 5 (see Statistical Methods below for more information).
Time frame: 6 weeks
If secondary objective 1 is met, determine whether learning to modulate motor cortex brain activity during at-home BCI rehabilitation increases the likelihood of benefitting from at-home BCI rehabilitation.
A significant relationship between the ability to modulate motor cortex brain activity during at-home BCI (as defined in the endpoint of secondary objective 1) and their change in FMA-UE from their pre- to post-test assessments (see Statistical Methods below for more information).
Time frame: 6 weeks
If secondary objective 1 is met, determine whether learning to modulate motor cortex brain activity during at-home BCI rehabilitation increases the likelihood of benefitting from at-home BCI rehabilitation.
A significant relationship between the ability to modulate motor cortex brain activity during at-home BCI (as defined in the endpoint of secondary objective 1) and their change in ARAT from their pre- to post-test assessments (see Statistical Methods below for more information).
Time frame: 6 weeks
If any of primary objectives 1-4 are met, show that the improvements in function achieved by responders to at-home BCI rehabilitation is maintained after the at-home BCI rehabilitation is discontinued.
At least one of the significant differences in FMA-UE scores observed between the pre- and post-tests are maintained at the follow-up session (see Statistical Methods below for more information).
Time frame: 10 weeks
If any of primary objectives 1-4 are met, show that the improvements in function achieved by responders to at-home BCI rehabilitation is maintained after the at-home BCI rehabilitation is discontinued.
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At least one of the significant differences in ARAT scores observed between the pre- and post-tests are maintained at the follow-up session (see Statistical Methods below for more information).
Time frame: 10 weeks