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NCT Number: NCT04286516

Brain Connections for Arm Movement After Stroke

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.

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Key information

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location status: Recruiting

Location contact

Amy Boos

CONTACT

[email protected]

(412) 648-4179

George F Wittenberg, MD PhD

CONTACT

[email protected]

(412) 360-6185

George F. Wittenberg, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Paired pulse transcranial magnetic stimulation

Primary outcomes

  1. Path length

    Time frame: Immediate (within 2 s after stimulation)

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

Secondary outcomes

  1. Times

    Time frame: Immediate (within 2 s after stimulation)

    Specific kinematic data from KINARM system: reaction time, movement time to reach target (units: ms)

  2. Velocities

    Time frame: Immediate (within 2 s after stimulation)

    maximum velocity reached during reach (units: cm/s)

  3. Accuracy

    Time frame: Immediate (within 2 s after stimulation)

    specific position data from KINARM system: target accuracy, distance from manipulandum position at end of one second reaching period to target center. (units: cm.)

  4. EMG

    Time frame: Immediate (within 2 s after stimulation)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Boos

CONTACT

[email protected]

(412) 648-4179

George F Wittenberg, MD PhD

CONTACT

[email protected]

(412) 360-6185

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Pittsburgh
  • VA Pittsburgh Healthcare System

Registry information

Official study title

Brain Areas That Control Reaching Movements After Stroke: Task-relevant Connectivity and Movement-synchronized Brain Stimulation

Acronym: CAM

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2020
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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