Imaging Laterality in Chronic Stroke Patients

NCT03584425 | Completed Early Phase 1 DMC

• 1 other identifier: 31250
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

In healthy individuals, unimanual movement (with either the left or right hand) is associated with activity in a network of predominantly contralateral brain regions, including the primary motor cortex (PMC). This laterality is often compromised following a middle cerebral artery (MCA) stroke. Neuroimaging studies of these patients have shown that unimanual movements with the effected hand are associated with elevated Blood Oxygen-Level Dependent (BOLD) signal in both the lesioned and the nonlesioned primary motor cortices. Elevated activity in the contralesional PMC is well-established in chronic stroke patients and is associated with poor motor rehabilitation outcomes. Yet the neurobiologic basis for this aberrant neural activity is equivocal. The overarching goal of this project is to determine the neurobiologic basis for elevated activity in the contralesional primary motor cortex.

Conditions

Stroke; Motor Cortex; Lesion

Keywords

BOLD Signal; Functional Magnetic Resonance Imaging; MR Spectroscopy; Anatomical Imaging; Kinematics

Outcome Measures

Primary Outcomes (1)

• Compare the ratio of gluatamte and gaba concentrations within the contralesional primary motor cortex

  Using spectroscopy investigators will determine if the ratio of glutamate/GABA is higher in stroke patients than controls. Furthermore, in healthy controls prepulse inhibition will be positively correlated with the concentration of GABA, and prepulse facilitation will be positively correlated with the concentration of glutamate. Although we expect this relationship to be true in both the controls and the stroke patients, variation from this pattern in the stroke patients would suggest that there is another factor beyond simple within-hemisphere measurements that is affecting the contralesional cortex activity.

  Through study completion, an average of two weeks

Secondary Outcomes (1)

• Quantify the relationship between neural activity and motor performance using the Rasch modified version of the Fugl-Meyer motor assessment battery to acquire three aspects of motor performance for all individuals in both groups.

  Through study completion, an average of two weeks

Study Arms (2)

Healthy Controls

EXPERIMENTAL

Subjects will undergo the following diagnostic tasks and assessments: Rasch Modified Version of the Fugl-Meyer Motor Assessment, Anatomical Image Acquisition, and the Functional MRI Task and Acquisition

Diagnostic Test: Rasch modified version of the Fugl-Meyer Motor assessment; Diagnostic Test: Anatomical image acquisition; Diagnostic Test: Functional MRI task and acquisition

Stroke Participants

EXPERIMENTAL

Subjects will undergo the following diagnostic tasks and assessments: Rasch Modified Version of the Fugl-Meyer Motor Assessment, Anatomical Image Acquisition, and the Functional MRI Task and Acquisition

Diagnostic Test: Rasch modified version of the Fugl-Meyer Motor assessment; Diagnostic Test: Anatomical image acquisition; Diagnostic Test: Functional MRI task and acquisition

Interventions

Rasch modified version of the Fugl-Meyer Motor assessment DIAGNOSTIC_TEST

All participants will receive a comprehensive clinical assessment of motor function including the Rasch modified version of the Fugl-Meyer Motor assessment and a kinematic assessment of unimanual and bimanual movements using a 45 sensor 3D active marker based motion capture system. The three primary measures investigated in the kinematics include: 1) movement efficiency, 2) movement smoothness, and 3) motor compensation.

Healthy Controls; Stroke Participants

Anatomical image acquisition DIAGNOSTIC_TEST

High-resolution structural scans will be obtained using an inversion recovery 3D spoiled gradient echo (3DSPGR) sequence using a matrix size of 256 x 256, field of view of 24 cm, section thickness of 1.5 mm with no gap between sections, and 128 slices, giving an in-plane resolution of 0.94 mm. This sequence will be used for anatomic overlays of the functional data and for spatial normalization to a standard atlas.

Healthy Controls; Stroke Participants

Functional MRI task and acquisition DIAGNOSTIC_TEST

Briefly, patients will be given two pressure-sensitive bulbs (one to be held in each hand and fastened lightly to their wrists with Velcro such that they do not drop it during the scan. During two 2½ minute runs they will be prompted to squeeze the bulb in either their affected or unaffected hand in blocks of 15 seconds. These blocks will be interspersed with blocks of rest. The pressure from the bulbs will be digitally recorded and quantified offline in order to: 1) verify that the patient was squeezing the ball, and 2) assess the presence of 'mirror movements' from the opposing hand that may inform the imaging results regarding loss of laterality).

Healthy Controls; Stroke Participants

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old of any race and ethnicity
• At least 2 cardiovascular risk factors (smoking, high blood pressure, high cholesterol, diabetes, overweight, age (\>55 for men, \>65 for women), family history of stroke).
• Left middle cerebral artery ischemic stroke with at least 6 month chronicity
• Right upper extremity weakness with a Rasch-modified Fugl-Meyer upper extremity score of 20 to 50
• Ability to voluntarily flex the affected elbow and shoulder from 10-75% of the normal range
• Ability to make a fist and relax the affected hand (note: this motion will be required in the functional MRI task)

You may not qualify if:

• Primary intracerebral hematoma or subarachnoid hemorrhage
• Bi-hemispheric ischemic strokes
• History of prior right-sided stroke or old infarct demonstrated on the CT or MRI or documented in medical records
• Other concomitant neurological disorders affecting upper extremity motor function
• Documented history of dementia before or after stroke
• Presence of any MRI, TMS, or transcranial direct current stimulation risk factors such as an electrically, magnetically or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system
• Pregnancy as the effect of MRI on the fetus is unknown, females of child bearing age must undergo a pregnancy test to confirm eligibility
• History of seizure disorder or post-stroke seizure
• Preexisting scalp lesion or wound or bone defect or hemicraniectomy
• Left-hand dominance (before the stroke in the stroke patients) as the typical pattern of laterality is not as strong in left-handed healthy individuals

Sponsors & Collaborators

• Medical University of South Carolina: lead
• MUSC Center for Biomedical Research Excellence in Stroke Recovery: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Colleen A Hanlon, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will enroll a total of 30 chronic stroke patients and 30 neurologically healthy controls matched for age and with at least 2 cardiovascular risk factors

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 12, 2018
• Study Start: December 15, 2014
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available immediately after first publication of the results. This is estimated to be at the end of 2018.
• Access Criteria: Interested parties should contact the Principal Investigator directly

Locations

US (1)