Cortical Biomarkers of Hand Function and Recovery After Injury

NCT03833518 | Terminated

• 1 other identifier: Pro00002855
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to collect data to support a VA grant submission to study fMRI and neurophysiological predictors of hand function and recovery during a robotic intervention in people with hand impairments due to stroke or spinal cord injury.

Conditions

Stroke; Spinal Cord Injuries

Keywords

hand; rehabilitation; motor cortex

Outcome Measures

Primary Outcomes (1)

• Number of participants that show significant finger-specific activation prior to the intervention

  The investigators will use functional magnetic resonance imaging (fMRI) to measure cortical activity relating to finger-specific brain activation before the rehabilitation intervention.

  Baseline, prior to intervention, week 1

Secondary Outcomes (2)

• Change from baseline finger strength after rehabilitation intervention

  After intervention, 12 weeks

• Change from baseline in finger dexterity after rehabilitation intervention

  After intervention, 12 weeks

Study Arms (1)

Hand impairment due to stroke or spinal cord injury

EXPERIMENTAL

Individuals who have experienced a sub-cortical stroke or a cervical spinal cord injury resulting in loss of hand function.

Other: Rehabilitation using motorized glove for stroke and spinal cord injury; Other: Functional MRI for stroke and spinal cord injury; Other: Transcranial magnetic stimulation (TMS) for stroke and spinal cord injury

Interventions

Rehabilitation using motorized glove for stroke and spinal cord injury OTHER

Individuals with hand impairment due to stroke or spinal cord injury will wear a motorized glove (Gloreha Sinfonia), or exoskeleton, as part of a rehabilitation protocol to improve dexterity. For each exercise, participants will attempt to do the action, receiving assistance as necessary via powered motors that can move each finger through its passive range of motion based on the current and target position.

Also known as: Exoskeleton therapy

Hand impairment due to stroke or spinal cord injury

Functional MRI for stroke and spinal cord injury OTHER

All participants will undergo 3 functional MRI's (fMRI's), two at the beginning of the experiment to document brain activity related to movement intention and ability to sense movement. A third MRI will be performed after the rehabilitation is completed to document the change in brain activity related to movement intention and ability to sense movement.

Also known as: fMRI

Hand impairment due to stroke or spinal cord injury

Transcranial magnetic stimulation (TMS) for stroke and spinal cord injury OTHER

Stimulation of the nervous system may be performed using a magnetic stimulator. TMS of the central nervous system is optional. Whether or not a participant undergoes TMS will depend upon their consent, their eligibility for TMS (i.e. no seizure history), and their neurological response to TMS.

Also known as: TMS

Hand impairment due to stroke or spinal cord injury

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal or corrected to normal vision
• Hand impairment due to spinal cord injury or stroke
• Weakness of fingers
• One year after stroke or spinal cord injury
• Some proprioception (can feel when finger is moved, without seeing)
• Minimal spasticity

You may not qualify if:

• Implanted metal with is unsafe for MRI
• Pregnant or expecting to become pregnant
• History of hand surgery which is under evaluation
• Cognitive or language issues that would interfere with following directions
• Other neurological disorder that would affect movement
• History of seizure or epilepsy
• Body weight \> 300 pounds

Sponsors & Collaborators

• VA Pittsburgh Healthcare System: lead
• University of Pittsburgh: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (10)

• Rathore SS, Hinn AR, Cooper LS, Tyroler HA, Rosamond WD. Characterization of incident stroke signs and symptoms: findings from the atherosclerosis risk in communities study. Stroke. 2002 Nov;33(11):2718-21. doi: 10.1161/01.str.0000035286.87503.31.

  PMID: 12411667 BACKGROUND

• Peckham PH, Keith MW, Kilgore KL, Grill JH, Wuolle KS, Thrope GB, Gorman P, Hobby J, Mulcahey MJ, Carroll S, Hentz VR, Wiegner A; Implantable Neuroprosthesis Research Group. Efficacy of an implanted neuroprosthesis for restoring hand grasp in tetraplegia: a multicenter study. Arch Phys Med Rehabil. 2001 Oct;82(10):1380-8. doi: 10.1053/apmr.2001.25910.

  PMID: 11588741 BACKGROUND

• Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.

  PMID: 15672628 BACKGROUND

• Doll U, Maurer-Burkhard B, Spahn B, Fromm B. Functional hand development in tetraplegia. Spinal Cord. 1998 Dec;36(12):818-21. doi: 10.1038/sj.sc.3100706.

  PMID: 9881729 BACKGROUND

• Fawcett JW. Recovery from spinal cord injury: regeneration, plasticity and rehabilitation. Brain. 2009 Jun;132(Pt 6):1417-8. doi: 10.1093/brain/awp121. Epub 2009 May 8. No abstract available.

  PMID: 19429905 BACKGROUND

• Nowak DA. The impact of stroke on the performance of grasping: usefulness of kinetic and kinematic motion analysis. Neurosci Biobehav Rev. 2008 Oct;32(8):1439-50. doi: 10.1016/j.neubiorev.2008.05.021. Epub 2008 May 23.

  PMID: 18582943 BACKGROUND

• Raghavan P, Petra E, Krakauer JW, Gordon AM. Patterns of impairment in digit independence after subcortical stroke. J Neurophysiol. 2006 Jan;95(1):369-78. doi: 10.1152/jn.00873.2005. Epub 2005 Oct 5.

  PMID: 16207778 BACKGROUND

• Lang CE, Schieber MH. Differential impairment of individuated finger movements in humans after damage to the motor cortex or the corticospinal tract. J Neurophysiol. 2003 Aug;90(2):1160-70. doi: 10.1152/jn.00130.2003. Epub 2003 Mar 26.

  PMID: 12660350 BACKGROUND

• Lang CE, Schieber MH. Reduced muscle selectivity during individuated finger movements in humans after damage to the motor cortex or corticospinal tract. J Neurophysiol. 2004 Apr;91(4):1722-33. doi: 10.1152/jn.00805.2003. Epub 2003 Dec 10.

  PMID: 14668295 BACKGROUND

• Wenzelburger R, Kopper F, Frenzel A, Stolze H, Klebe S, Brossmann A, Kuhtz-Buschbeck J, Golge M, Illert M, Deuschl G. Hand coordination following capsular stroke. Brain. 2005 Jan;128(Pt 1):64-74. doi: 10.1093/brain/awh317. Epub 2004 Oct 7.

  PMID: 15471902 BACKGROUND

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Jennifer Collinger, PhD

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Biomedical Engineer

Model Details: This is a pilot study to collect data to support a VA grant submission to study fMRI and neurophysiological predictors of hand function and recovery during a robotic intervention in people with hand impairments due to stroke or spinal cord injury.

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 7, 2019
• Study Start: September 1, 2019
• Primary Completion: August 15, 2020
• Study Completion: October 15, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)