Cortical Biomarkers of Hand Function and Recovery After Injury
Primary Purpose
Stroke, Spinal Cord Injuries
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rehabilitation using motorized glove for stroke and spinal cord injury
Functional MRI for stroke and spinal cord injury
Transcranial magnetic stimulation (TMS) for stroke and spinal cord injury
Sponsored by
About this trial
This is an interventional basic science trial for Stroke focused on measuring hand, rehabilitation, motor cortex
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hand impairment due to stroke or spinal cord injury
Arm Description
Individuals who have experienced a sub-cortical stroke or a cervical spinal cord injury resulting in loss of hand function.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from baseline finger strength after rehabilitation intervention
The investigators will assess finger strength of participants both before and after the rehabilitation intervention. The change in in finger strength will serve as a secondary outcome measure.
Change from baseline in finger dexterity after rehabilitation intervention
The investigators will assess each participant's ability to isolate movement of individual fingers both before and after the rehabilitation intervention. The change in this measure of dexterity will serve as a secondary outcome measure.
Full Information
NCT ID
NCT03833518
First Posted
February 4, 2019
Last Updated
April 30, 2021
Sponsor
VA Pittsburgh Healthcare System
Collaborators
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT03833518
Brief Title
Cortical Biomarkers of Hand Function and Recovery After Injury
Official Title
Cortical Biomarkers of Hand Function and Recovery After Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
We only enrolled one participant, and this participant was withdrawn prior to collecting any useful data. Then, COVID. Now, Dr. Collinger's faculty tenure with the VA ended.
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Pittsburgh Healthcare System
Collaborators
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The loss of arm and hand function after cervical spinal cord injury (SCI) limits independence and increases the cost of care. As a result, Veterans with tetraplegia prioritize restoration of hand and arm function over all other rehabilitation goals. Similar to SCI, stroke of supraspinal areas involved in motor control results in acute movement deficits in more than 85% of survivors. Despite advances in treatment and rehabilitation, 50% of stroke survivors have persistent hand impairment. The loss of hand function and dexterity limits the ability to perform many activities of daily living, and thus limits independence. Since motor deficits are often permanent after SCI and stroke, new strategies are needed to restore dexterous hand function.
Advances in functional imaging have enabled the measurement of finger-related activation patterns in somatosensory cortex, but little is known about how these representational patterns are impacted when hand function is lost. Prior studies of gross movements have reported reorganization of cortical activity after injury. The investigators aim to improve dexterous hand function by increasing our understanding of finger-related cortical reorganization after lesions to the spinal or supraspinal structures. This understanding could allow discrimination between adaptive and maladaptive patterns underlying hand function and guide restorative therapies. Additionally, imaging biomarkers of injury often track with functional recovery.
The aim is to improve dexterous hand function by increasing our understanding of finger-related cortical reorganization after lesions to the spinal or supraspinal structures. This understanding could allow discrimination between adaptive and maladaptive patterns underlying hand function and guide restorative therapies. Additionally, imaging biomarkers of injury often track with functional recovery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spinal Cord Injuries
Keywords
hand, rehabilitation, motor cortex
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand impairment due to stroke or spinal cord injury
Arm Type
Experimental
Arm Description
Individuals who have experienced a sub-cortical stroke or a cervical spinal cord injury resulting in loss of hand function.
Intervention Type
Other
Intervention Name(s)
Rehabilitation using motorized glove for stroke and spinal cord injury
Other Intervention Name(s)
Exoskeleton therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Functional MRI for stroke and spinal cord injury
Other Intervention Name(s)
fMRI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Transcranial magnetic stimulation (TMS) for stroke and spinal cord injury
Other Intervention Name(s)
TMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants that show significant finger-specific activation prior to the intervention
Description
The investigators will use functional magnetic resonance imaging (fMRI) to measure cortical activity relating to finger-specific brain activation before the rehabilitation intervention.
Time Frame
Baseline, prior to intervention, week 1
Secondary Outcome Measure Information:
Title
Change from baseline finger strength after rehabilitation intervention
Description
The investigators will assess finger strength of participants both before and after the rehabilitation intervention. The change in in finger strength will serve as a secondary outcome measure.
Time Frame
After intervention, 12 weeks
Title
Change from baseline in finger dexterity after rehabilitation intervention
Description
The investigators will assess each participant's ability to isolate movement of individual fingers both before and after the rehabilitation intervention. The change in this measure of dexterity will serve as a secondary outcome measure.
Time Frame
After intervention, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Collinger, PhD
Organizational Affiliation
US Department of Veterans Affairs
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Research information will not be shared with anyone outside of the research team.
Citations:
PubMed Identifier
12411667
Citation
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.
Results Reference
background
PubMed Identifier
11588741
Citation
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.
Results Reference
background
PubMed Identifier
15672628
Citation
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.
Results Reference
background
PubMed Identifier
9881729
Citation
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.
Results Reference
background
PubMed Identifier
19429905
Citation
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.
Results Reference
background
PubMed Identifier
18582943
Citation
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.
Results Reference
background
PubMed Identifier
16207778
Citation
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.
Results Reference
background
PubMed Identifier
12660350
Citation
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.
Results Reference
background
PubMed Identifier
14668295
Citation
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.
Results Reference
background
PubMed Identifier
15471902
Citation
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.
Results Reference
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Cortical Biomarkers of Hand Function and Recovery After Injury
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