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Brain Connections for Arm Movement After Stroke (CAM)

Primary Purpose

Stroke, Brain Disease, Central Nervous System Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion Criteria (control participants):

  • Be 45-90 years of age
  • Have adequate language and neurocognitive function to participate in training and testing
  • Be medically stable to participate in the study
  • Be English speaking

Inclusion Criteria (participants with stroke):

  • Be 45-90 years of age
  • Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnosis
  • Stroke onset at least 6 months before enrollment
  • Subcortical stroke (ex: internal capsule, deep white matter of posterior frontal lobe)
  • Present with mild to moderate arm dysfunction
  • Be medically stable to participate in the study
  • Be English speaking

Exclusion Criteria:

(for both groups)

  • Unable to give informed consent
  • Have a serious complicating medical illness that would preclude participation
  • Contractures or orthopedic problems limiting range of joint motion in the potential study arm or other impairments that would interfere with the study activities
  • Visual loss such that the subject would not be able to see the test patterns on the robot computer monitor
  • Unable to comply with requirements of the study
  • Enrollment in another greater-than-minimal risk study
  • Presence of medical condition or implant that prevents safe administration of TMS or MRI
  • Pregnancy

Sites / Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reaching with TMS

Arm Description

All participants enrolled in this group will receive TMS while performing reaching movements in a robotic system.

Outcomes

Primary Outcome Measures

Path length
Movement path length in centimeters from KINARM system during the one second reaching period. (units: cm)

Secondary Outcome Measures

Times
Specific kinematic data from KINARM system: reaction time, movement time to reach target (units: ms)
Velocities
maximum velocity reached during reach (units: cm/s)
Accuracy
specific position data from KINARM system: target accuracy, distance from manipulandum position at end of one second reaching period to target center. (units: cm.)
EMG
Electromyographic data from surface electrodes on biceps, triceps, anterior deltoid, and posterior deltoid muscles - These signals will be rectified and normalized to the maximum values during practice reaches. (units: mV/mV - dimensionless).

Full Information

First Posted
January 21, 2020
Last Updated
July 11, 2023
Sponsor
VA Office of Research and Development
Collaborators
VA Pittsburgh Healthcare System, University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT04286516
Brief Title
Brain Connections for Arm Movement After Stroke
Acronym
CAM
Official Title
Brain Areas That Control Reaching Movements After Stroke: Task-relevant Connectivity and Movement-synchronized Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
VA Pittsburgh Healthcare System, University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to use Transcranial Magnetic Stimulation (TMS) while subjects are making reaching movements in a robotic arm device in order to discover how different brain areas control movement before and after stroke and when these brain areas are most sensitive to TMS.
Detailed Description
The general objective of this application is to study reorganization of network interactions following a common type of subcortical stroke (i.e. internal capsule) with mechanistic studies using noninvasive neurophysiology in humans. The goal is to obtain pilot data and to demonstrate the feasibility of the approach that combines transcranial magnetic stimulation (TMS) with reaching in an advanced exoskeleton robot. As reaching is an essential part of many daily activities, this approach will have beneficial impacts on the quality of life of these stroke patients. The central hypothesis is that bilateral premotor cortical areas, dorsal (PMd) more so than ventral (PMv,) develops greater connectivity with primary motor cortex (M1) after stroke and thus better ability to produce motor outputs that support reaching with the paretic arm. When there is more damage to the corticospinal tract, contralesional areas will take on a greater role. The relationship between connectivity, behavioral effects of stimulation and motor performance will be established. These findings will allow the investigators to formulate clear hypotheses about which premotor area should be modulated with TMS, depending on stroke extent and deficits in motor control, when reaching the stage of proposing a treatment trial. Increased knowledge of the dynamic changes of physiological interactions during various phases of reaching movements will allow a more defined study regarding the role of premotor areas in recovery of motor function after stroke, and a novel treatment protocol that delivers precisely timed stimulations during practice of reaching movements. Ultimately, the investigators can test these novel treatments in clinical trials and compare their impact to other, less specific, neuromodulatory methods such as transcranial direct current stimulation. This study will also lay the groundwork for collaboration in brain computer interface and non-human primate investigations in the mechanisms and treatment of motor deficits after stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Brain Disease, Central Nervous System Diseases, Nervous System Diseases, Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot project
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reaching with TMS
Arm Type
Experimental
Arm Description
All participants enrolled in this group will receive TMS while performing reaching movements in a robotic system.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
Paired pulse transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
Path length
Description
Movement path length in centimeters from KINARM system during the one second reaching period. (units: cm)
Time Frame
Immediate (within 2 s after stimulation)
Secondary Outcome Measure Information:
Title
Times
Description
Specific kinematic data from KINARM system: reaction time, movement time to reach target (units: ms)
Time Frame
Immediate (within 2 s after stimulation)
Title
Velocities
Description
maximum velocity reached during reach (units: cm/s)
Time Frame
Immediate (within 2 s after stimulation)
Title
Accuracy
Description
specific position data from KINARM system: target accuracy, distance from manipulandum position at end of one second reaching period to target center. (units: cm.)
Time Frame
Immediate (within 2 s after stimulation)
Title
EMG
Description
Electromyographic data from surface electrodes on biceps, triceps, anterior deltoid, and posterior deltoid muscles - These signals will be rectified and normalized to the maximum values during practice reaches. (units: mV/mV - dimensionless).
Time Frame
Immediate (within 2 s after stimulation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria (control participants): Be 45-90 years of age Have adequate language and neurocognitive function to participate in training and testing Be medically stable to participate in the study Be English speaking Inclusion Criteria (participants with stroke): Be 45-90 years of age Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnosis Stroke onset at least 6 months before enrollment Subcortical stroke (ex: internal capsule, deep white matter of posterior frontal lobe) Present with mild to moderate arm dysfunction Be medically stable to participate in the study Be English speaking Exclusion Criteria: (for both groups) Unable to give informed consent Have a serious complicating medical illness that would preclude participation Contractures or orthopedic problems limiting range of joint motion in the potential study arm or other impairments that would interfere with the study activities Visual loss such that the subject would not be able to see the test patterns on the robot computer monitor Unable to comply with requirements of the study Enrollment in another greater-than-minimal risk study Presence of medical condition or implant that prevents safe administration of TMS or MRI Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Boos
Phone
(412) 648-4179
Email
amy.boos@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
George F Wittenberg, MD PhD
Phone
(412) 360-6185
Email
George.Wittenberg@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George F. Wittenberg, MD PhD
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George F Wittenberg, MD PhD
Phone
412-360-6185
Email
George.Wittenberg@va.gov
First Name & Middle Initial & Last Name & Degree
Amy Boos
Phone
(412) 648-4179
Email
amy.boos@pitt.edu
First Name & Middle Initial & Last Name & Degree
George F. Wittenberg, MD PhD

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
12376621
Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Brain Connections for Arm Movement After Stroke

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