National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

Stroke Clinical Trial

Official title:

IpsiHand Device Use in Hemiparetic Stroke Population to Assess Home Based EEG System Candidacy for BCI Rehabilitation of the Upper Extremity and the Efficacy of a Full Remote Home Based BCI Therapy - A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05965713
• Other study ID #: National Remote IpsiHand Study
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: July 2023
• Source: Neurolutions, Inc.
• Contact: Kelly Carr, MOT, OTR/L
• Phone: 314-272-2575
• Email: kcarr[@]neurolutions.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to define the efficacy of fully remote home-based BCI therapy in chronic hemiparetic subcortical stroke patients. A randomized controlled study using the integrated remote BCI system will be tested against standard exercise therapy to determine the efficacy of motor improvement in chronic stroke patients with an upper extremity hemiparesis. Specifically, the integrated BCI system will include 1) the remote screening and motor assessment system for the upper extremity and 2) the BCI-controlled robotic hand exoskeleton (i.e. IpsiHand).

Description:

The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor impaired stroke survivors. This ultimate goal is to develop a system that allows for enhanced functional capability and works consistently over a long-term basis and is accessible remotely no matter location or access to healthcare. In developing a new rehabilitation method, the researchers hope to create a system that allows for closed loop feedback through a robotic hand orthosis on the motor impaired side of stroke patients in response to intended movements of the muscles. The method, if successful, would represent an ideal, non-invasive method of promoting motor learning and recovery in stroke survivors. The ability to operate robotic hand orthosis using electrical signals of the brain is rapidly leaving the realm of science fiction and becoming a realistic goal of the clinical community. The current advances in BCI controlled neuroprosthetics could have immeasurable influence on adult patients with severe motor impairments from stroke. Even further on the horizon the insights developed from such work could substantively alter the way all stroke patients are treated and rehabilitated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 31, 2025
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Adults age (18-85)

2. Adults who sustained a CVA

3. Have upper extremity hemiparesis/hemiplegia

4. Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.

Exclusion Criteria:

1. Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.

2. Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded.

3. Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit.

4. Participants who have receptive aphasia and unable to follow written directions will be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded.

5. Participants receiving any formal upper extremity therapy will be excluded.

6. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded.

7. Participants who are pregnant or breast-feeding will be excluded.

8. Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Spasticity as Sequela of Stroke
• Stroke

Intervention

Device:
• Neurolutions IpsiHand System
The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.

Other:
• Standard of Care - Home Exercise Program for Upper Extremity
Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks

Locations

Country	Name	City	State
United States	Neurolutions	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Neurolutions, Inc.	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper Extremity Remote Fugl-Meyer	Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.	Baseline assessment
Primary	Upper Extremity Remote Fugl-Meyer	Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.	2 week assessment
Primary	Upper Extremity Remote Fugl-Meyer	Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.	4 week assessment
Primary	Upper Extremity Remote Fugl-Meyer	Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.	6 week assessment
Primary	Upper Extremity Remote Fugl-Meyer	Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.	8 week assessment
Primary	Upper Extremity Remote Fugl-Meyer	Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.	10 week assessment
Primary	Upper Extremity Remote Fugl-Meyer	Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.	12 week assessment (outcome assessment)
Secondary	Motor Activity Log	Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score= 140	Baseline assessment
Secondary	Motor Activity Log	Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score=140	12 week completion
Secondary	Gross Grasp Strength	Evaluation of gross grasp strength via dynamometry; lowest score=0 lbs, maximal score 150lbs	Baseline assessment
Secondary	Gross Grasp Strength	Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs	12 week completion

External Links

•   A variables associated with occupational and physical therapy stroke rehabilitation utilization and outcomes
•   An evaluation framework for a rural home-based telerehabilitation network
•   Barriers to care among racial/ethnic groups under managed care
•   Brain-Computer Interface in Stroke Rehabilitation
•   Brain-computer interface with somatosensory feedback improves functional recovery from severe hemiplegia due to chronic stroke
•   Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke
•   Clinical practice. Rehabilitation after stroke
•   Disparities in postacute stroke rehabilitation disposition to acute inpatient rehabilitation vs. home: findings from the North Carolina Hospital Discharge Database
•   Efficacy of brain-computer interface-driven neuromuscular electrical stimulation for chronic paresis after stroke
•   Feasibility of a new application of noninvasive Brain Computer Interface (BCI): a case study of training for recovery of volitional motor control after stroke
•   Inequities in access to inpatient rehabilitation after stroke: an international scoping review
•   Rehabilitation with poststroke motor recovery: a review with a focus on neural plasticity
•   Stroke patients' and carers' perception of barriers to accessing stroke information
•   Theta-gamma coupling as a cortical biomarker of brain-computer interface-mediated motor recovery in chronic stroke
•   Think to move: a neuromagnetic brain-computer interface (BCI) system for chronic stroke