Brain Connections for Arm Movement After Stroke

NCT04286516 | Recruiting FDA Device

• 2 other identifiers: N3511-RPro00003163
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Brain Disease; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Path length

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

  Immediate (within 2 s after stimulation)

Secondary Outcomes (4)

• Times

  Immediate (within 2 s after stimulation)

• Velocities

  Immediate (within 2 s after stimulation)

• Accuracy

  Immediate (within 2 s after stimulation)

• EMG

  Immediate (within 2 s after stimulation)

Study Arms (1)

Reaching with TMS

EXPERIMENTAL

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

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Paired pulse transcranial magnetic stimulation

Reaching with TMS

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Be 45-90 years of age
• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Pittsburgh Healthcare System: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

Related Publications (13)

• Johansen-Berg H, Rushworth MF, Bogdanovic MD, Kischka U, Wimalaratna S, Matthews PM. The role of ipsilateral premotor cortex in hand movement after stroke. Proc Natl Acad Sci U S A. 2002 Oct 29;99(22):14518-23. doi: 10.1073/pnas.222536799. Epub 2002 Oct 10.

  PMID: 12376621 BACKGROUND

• Butefisch CM, Kleiser R, Korber B, Muller K, Wittsack HJ, Homberg V, Seitz RJ. Recruitment of contralesional motor cortex in stroke patients with recovery of hand function. Neurology. 2005 Mar 22;64(6):1067-9. doi: 10.1212/01.WNL.0000154603.48446.36.

  PMID: 15781831 BACKGROUND

• Corbett D, Carmichael ST, Murphy TH, Jones TA, Schwab ME, Jolkkonen J, Clarkson AN, Dancause N, Weiloch T, Johansen-Berg H, Nilsson M, McCullough LD, Joy MT. Enhancing the Alignment of the Preclinical and Clinical Stroke Recovery Research Pipeline: Consensus-Based Core Recommendations From the Stroke Recovery and Rehabilitation Roundtable Translational Working Group. Neurorehabil Neural Repair. 2017 Aug;31(8):699-707. doi: 10.1177/1545968317724285.

  PMID: 28803530 BACKGROUND

• Nudo RJ, Wise BM, SiFuentes F, Milliken GW. Neural substrates for the effects of rehabilitative training on motor recovery after ischemic infarct. Science. 1996 Jun 21;272(5269):1791-4. doi: 10.1126/science.272.5269.1791.

  PMID: 8650578 BACKGROUND

• Frost SB, Barbay S, Friel KM, Plautz EJ, Nudo RJ. Reorganization of remote cortical regions after ischemic brain injury: a potential substrate for stroke recovery. J Neurophysiol. 2003 Jun;89(6):3205-14. doi: 10.1152/jn.01143.2002.

  PMID: 12783955 BACKGROUND

• Dancause N, Barbay S, Frost SB, Zoubina EV, Plautz EJ, Mahnken JD, Nudo RJ. Effects of small ischemic lesions in the primary motor cortex on neurophysiological organization in ventral premotor cortex. J Neurophysiol. 2006 Dec;96(6):3506-11. doi: 10.1152/jn.00792.2006. Epub 2006 Sep 20.

  PMID: 16987930 BACKGROUND

• Dancause N, Barbay S, Frost SB, Plautz EJ, Chen D, Zoubina EV, Stowe AM, Nudo RJ. Extensive cortical rewiring after brain injury. J Neurosci. 2005 Nov 2;25(44):10167-79. doi: 10.1523/JNEUROSCI.3256-05.2005.

  PMID: 16267224 BACKGROUND

• Quessy S, Cote SL, Hamadjida A, Deffeyes J, Dancause N. Modulatory Effects of the Ipsi and Contralateral Ventral Premotor Cortex (PMv) on the Primary Motor Cortex (M1) Outputs to Intrinsic Hand and Forearm Muscles in Cebus apella. Cereb Cortex. 2016 Oct;26(10):3905-20. doi: 10.1093/cercor/bhw186. Epub 2016 Jul 29.

  PMID: 27473318 BACKGROUND

• Kurata K. Premotor cortex of monkeys: set- and movement-related activity reflecting amplitude and direction of wrist movements. J Neurophysiol. 1993 Jan;69(1):187-200. doi: 10.1152/jn.1993.69.1.187.

  PMID: 8433130 BACKGROUND

• Davare M, Duque J, Vandermeeren Y, Thonnard JL, Olivier E. Role of the ipsilateral primary motor cortex in controlling the timing of hand muscle recruitment. Cereb Cortex. 2007 Feb;17(2):353-62. doi: 10.1093/cercor/bhj152. Epub 2006 Mar 8.

  PMID: 16525129 BACKGROUND

• Weiller C, Ramsay SC, Wise RJ, Friston KJ, Frackowiak RS. Individual patterns of functional reorganization in the human cerebral cortex after capsular infarction. Ann Neurol. 1993 Feb;33(2):181-9. doi: 10.1002/ana.410330208.

  PMID: 8434880 BACKGROUND

• Wittenberg GF, Richards LG, Jones-Lush LM, Roys SR, Gullapalli RP, Yang S, Guarino PD, Lo AC. Predictors and brain connectivity changes associated with arm motor function improvement from intensive practice in chronic stroke. F1000Res. 2016 Aug 31;5:2119. doi: 10.12688/f1000research.8603.2. eCollection 2016.

  PMID: 28357039 BACKGROUND

• Haddadshargh G, de Freitas RM, Mak J, Boos A, Fang X, Collinger JL, McKernan G, Zhan L, Liu F, Wittenberg GF. Mapping the Causal Roles of Non-Primary Motor Areas in Human Reach Planning and Execution. Hum Brain Mapp. 2026 Feb 1;47(2):e70465. doi: 10.1002/hbm.70465.

  PMID: 41641924 DERIVED

MeSH Terms

Conditions

Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Vascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• George F. Wittenberg, MD PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Boos

CONTACT

(412) 648-4179; amy.boos2@va.gov

George F Wittenberg, MD PhD

CONTACT

(412) 360-6185; George.Wittenberg@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Controlled, nonrandomized experimental study

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 27, 2020
• Study Start: January 10, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)