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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axem Home | Experimental | Patients receive at-home access to Axem Home system for duration of the study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axem Home | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 6 in the Fugl-Meyer Upper-Extremity subscale. | 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. | 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. | 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. | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Friesen, PhD | Contact | 2049798755 | chris@axemneuro.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D010291 | Paresis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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). |
| 6 weeks |
| 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). | 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). | 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). | 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. | 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). | 10 weeks |