Cortical Biomarkers of Hand Function and Recovery After Injury

Stroke Clinical Trial

Official title:

Cortical Biomarkers of Hand Function and Recovery After Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03833518
• Other study ID #: Pro00002855
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: April 2021
• Source: VA Pittsburgh Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Stroke
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
VA Pittsburgh Healthcare System	University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (10)

Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. — View Citation

Doll U, Maurer-Burkhard B, Spahn B, Fromm B. Functional hand development in tetraplegia. Spinal Cord. 1998 Dec;36(12):818-21. — View 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. — View 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. Epub 2003 Mar 26. — View 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. Epub 2003 Dec 10. — View 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. Review. — View 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. — View 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. Epub 2005 Oct 5. — View 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. — View Citation

Wenzelburger R, Kopper F, Frenzel A, Stolze H, Klebe S, Brossmann A, Kuhtz-Buschbeck J, Gölge M, Illert M, Deuschl G. Hand coordination following capsular stroke. Brain. 2005 Jan;128(Pt 1):64-74. Epub 2004 Oct 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	After intervention, 12 weeks
Secondary	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.	After intervention, 12 weeks