Clinical trial NCT05374486: EEG Brain-Machine Interface Control of an Upper-Limb Robotic Exoskeleton for Robot-Assisted Rehabilitation After Stroke
Official title: PFI-RP: Smart Co-robot System for Cost-Effective Patient-Centered Robotic Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Hemiparesis
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: TIRR Memorial Hermann
name: The University of Texas Health Science Center, Houston
First posted: 2022-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to develop a clinically feasible, low-cost, nonsurgical neurorobotic system for restoring function to motor-impaired stroke survivors that can be used at the clinic or at home. Moreover, another goal is to understand how physical rehabilitation assisted by robotic device combined with electroencephalograph (EEG) can benefit adults who have had stroke to improve functions of their weaker arm.

The proposed smart co-robot training system (NeuroExo) is based on a physical upper-limb robotic exoskeleton commanded by a non-invasive brain machine interface (BMI) based on scalp EEG to actively include the participant in the control loop .

The study will demonstrate that the Neuroexo smart co-robot arm training system is feasible and effective in improving arm motor functions in the stroke population for their use at home.The NeuroExo study holds the promise to be cost-effective patient-centered neurorehabilitation system for improving arm functions after stroke.

Detailed description: This study has two phases: The first phase will consist of baseline recordings for system calibration and training sessions to be conducted in a clinical setting. The second phase will consist of NeuroExo BMI-exo neurotherapy to be conducted at the participant's home. Throughout the study and after completion of the study, movement and brain activity will be analyzed to assess function of the affected upper extremity and changes in brain activity associated with the neurotherapy.

Eligibility criteria: Inclusion Criteria:

* subjects between the ages of 20-65, male or female,
* mild-to- moderate unilateral stroke confirmed by brain CT or MRI scan and manifested by a Glasgow Coma scale (GCS) score between 15 and 9 documented within 6 months,
* the ability to perform 20deg of active wrist/elbow for upper limb robotic movement on the affected side, no planned alteration in lower/upper- extremity therapy/medication for muscle tone during course of study,
* Anticipated length of needed acute interdisciplinary rehabilitation of 30 days or more.
* Patients are required to have a MMSE\>=24 to rule out those with cognitive impairments.
* Patients will have to have normal/near normal strength in one upper/lower extremity and appreciable weakness in the other upper/lower extremity.

Exclusion Criteria:

* history of traumatic brain injury prior to the current episode,
* Severe neurologic or psychiatric condition preventing participation in rehabilitation and physical therapy activities (patients unable or unwilling to receive instruction and effectively complete a simple assigned task as determined by MMSE\>=24 specified in inclusion criteria).
* Women and minorities will be recruited as long as they meet the inclusion criteria.

Primary outcomes:
measure: Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
timeFrame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
measure: Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude
timeFrame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
measure: Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
timeFrame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
measure: Movement Quality as Assessed by Exoskeleton Kinematics
timeFrame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
measure: Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
timeFrame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
measure: Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak
timeFrame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Secondary outcomes:
measure: Score on Action Research Arm Test (ARAT)
timeFrame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
measure: Score on Jebsen-Taylor Hand Function Test (JTHFT)
timeFrame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
measure: Grip Strength
timeFrame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
measure: Pinch Strength
timeFrame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
state: Texas
city: Houston
country: United States
facility: TIRR Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Jose L Contreras-Vidal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Gerard Francisco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhagat NA, Yozbatiran N, Sullivan JL, Paranjape R, Losey C, Hernandez Z, Keser Z, Grossman R, Francisco GE, O'Malley MK, Contreras-Vidal JL. Neural activity modulations and motor recovery following brain-exoskeleton interface mediated stroke rehabilitation. Neuroimage Clin. 2020;28:102502. doi: 10.1016/j.nicl.2020.102502. Epub 2020 Nov 19.
citation: Sullivan JL, Bhagat NA, Yozbatiran N, Paranjape R, Losey CG, Grossman RG, Contreras-Vidal JL, Francisco GE, O'Malley MK. Improving robotic stroke rehabilitation by incorporating neural intent detection: Preliminary results from a clinical trial. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:122-127. doi: 10.1109/ICORR.2017.8009233.
citation: Bhagat NA, Venkatakrishnan A, Abibullaev B, Artz EJ, Yozbatiran N, Blank AA, French J, Karmonik C, Grossman RG, O'Malley MK, Francisco GE, Contreras-Vidal JL. Design and Optimization of an EEG-Based Brain Machine Interface (BMI) to an Upper-Limb Exoskeleton for Stroke Survivors. Front Neurosci. 2016 Mar 31;10:122. doi: 10.3389/fnins.2016.00122. eCollection 2016.
citation: Bhagat NA, French J, Venkatakrishnan A, Yozbatiran N, Francisco GE, O'Malley MK, Contreras-Vidal JL. Detecting movement intent from scalp EEG in a novel upper limb robotic rehabilitation system for stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:4127-4130. doi: 10.1109/EMBC.2014.6944532.
citation: Venkatakrishnan A, Francisco GE, Contreras-Vidal JL. Applications of Brain-Machine Interface Systems in Stroke Recovery and Rehabilitation. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):93-105. doi: 10.1007/s40141-014-0051-4.