Safety and Feasibility of eGlove

Stroke Clinical Trial

Official title:

Electroencephalographic Correlates of Glove-stretch Therapy Post-stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05345301
• Other study ID #: STU00216276
• Status: Completed
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: September 14, 2022

Study information

• Verified date: July 2023
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure how cortical signals improve in stroke participants after passive hand stretching therapy from a robotic glove.

Description:

After experiencing a stroke event, many individuals are left with life-long motor impairments in their upper extremity. However, motor recovery for stroke survivors is not fully understood. One of the challenges to understand the mechanisms behind recovery is the capability of the brain to reorganize and re-activate areas affected by the stroke. Brain computer interface (BCI) has shown promise in previous studies to improve motor capabilities of individuals with damaged nervous systems by reactivating damaged motor pathways.

In order to understand how BCI can be incorporated into upper extremity rehabilitation, investigators must first lay the groundwork of measuring neural activity and its relation to muscle activity in individuals who have experienced a stroke. While instructing participants to open and close their hand, investigators will measure (1) neural activity, called sensorimotor rhythms (SMRs), using a electrophysiological (EEG) cap, and (2) muscle activity using wireless electromyography (EMGs). What the investigators are specifically looking for is an event in the neural activity in between movement initiation and termination called event related desynchronization (ERD). The investigators of this study hypothesize that there is greater activation of ERDs in stroke's subjects SMR activity after completing finger extension and flexion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 14, 2022
• Est. primary completion date: September 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ischemic or hemorrhagic stroke (6 months post stroke)

• Hemiparesis

• Some degree of hand and finger movement capability

• a moderate impairment (Fugl-Meyer score between 15-50)

Exclusion Criteria:

• Individuals under the age of 18

• Bilateral paresis

• Hand pain and/or extreme articular contractures on the finger joints (Modified Ashworth Scale of 4)

• Botox injection to the affected upper extremity within the previous 4 months

• Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment

Related Conditions & MeSH terms

• Stroke

Intervention

Diagnostic Test:
• Event related desynchronization measurement
Individuals will spend one hour and receive cues to open or close their hand while wearing a EEG cap and EMG sensors on their forearm.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

References & Publications (12)

Ang KK, Guan C, Chua KS, Phua KS, Wang C, Chin ZY, Zhou L, Tang KY, Joseph GJ, Kuah C. A clinical study of motor imagery BCI performance in stroke by including calibration data from passive movement. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6603-6. — View Citation

Buch E, Weber C, Cohen LG, Braun C, Dimyan MA, Ard T, Mellinger J, Caria A, Soekadar S, Fourkas A, Birbaumer N. Think to move: a neuromagnetic brain-computer interface (BCI) system for chronic stroke. Stroke. 2008 Mar;39(3):910-7. doi: 10.1161/STROKEAHA.1 — View Citation

Dobkin B, Barbeau H, Deforge D, Ditunno J, Elashoff R, Apple D, Basso M, Behrman A, Harkema S, Saulino M, Scott M; Spinal Cord Injury Locomotor Trial Group. The evolution of walking-related outcomes over the first 12 weeks of rehabilitation for incomplete — View Citation

McFarland DJ, Sarnacki WA, Wolpaw JR. Effects of training pre-movement sensorimotor rhythms on behavioral performance. J Neural Eng. 2015 Dec;12(6):066021. doi: 10.1088/1741-2560/12/6/066021. Epub 2015 Nov 3. — View Citation

Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033. — View Citation

Peles O, Werner-Reiss U, Bergman H, Israel Z, Vaadia E. Phase-Specific Microstimulation Differentially Modulates Beta Oscillations and Affects Behavior. Cell Rep. 2020 Feb 25;30(8):2555-2566.e3. doi: 10.1016/j.celrep.2020.02.005. — View Citation

Prasad G, Herman P, Coyle D, McDonough S, Crosbie J. Applying a brain-computer interface to support motor imagery practice in people with stroke for upper limb recovery: a feasibility study. J Neuroeng Rehabil. 2010 Dec 14;7:60. doi: 10.1186/1743-0003-7-6 — View Citation

Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a con — View 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. — View Citation

Thielbar KO, Triandafilou KM, Fischer HC, O'Toole JM, Corrigan ML, Ochoa JM, Stoykov ME, Kamper DG. Benefits of Using a Voice and EMG-Driven Actuated Glove to Support Occupational Therapy for Stroke Survivors. IEEE Trans Neural Syst Rehabil Eng. 2017 Mar; — View Citation

Triandafilou KM, Kamper DG. Carryover effects of cyclical stretching of the digits on hand function in stroke survivors. Arch Phys Med Rehabil. 2014 Aug;95(8):1571-6. doi: 10.1016/j.apmr.2014.04.008. Epub 2014 May 2. — View Citation

Yuan H, He B. Brain-computer interfaces using sensorimotor rhythms: current state and future perspectives. IEEE Trans Biomed Eng. 2014 May;61(5):1425-35. doi: 10.1109/TBME.2014.2312397. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of activation of Event Related Desynchronization	Sensorimotor neural activity	1 hour