ClinicalTrials.gg
RecruitingNCT04286516CAMUpdated Jun 2, 2026

Brain Connections for Arm Movement After Stroke

An interventional study of Transcranial Magnetic Stimulation in Stroke, Brain Disease and Central Nervous System Diseases, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 45 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2020; still recruiting 6 years 10 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Not applicable
Ages
45 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 87 studies in Stroke by VA Office of Research and Development — 13 open to participants now, 17 under way, none of them phase 3. Stroke · VA Office of Research and Development.

Planned enrollment
16th of 79
76 · median 38
Started
2020
with 5 others
No phase
67 of 87
9 open now
Primary completion
2026-09
later than 2 of 16 live
Registered
63rd of 87
by date

Among the 87 studies in Stroke by VA Office of Research and Development, this one is the 16th largest by planned enrollment of the 79 interventional ones that give a count, is one of 6 that started in 2020, is one of 67 with no phase, reaches primary completion later than 2 of the 16 other live ones, and was the 63rd registered.

Stroke

8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.

Browse Stroke studies →

Open to participants now

13 of the 87 studies in Stroke by VA Office of Research and Development are open now, in 1 country. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 13 open studies →

Where they have run

Who these studies take

Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.

This study: 45 Years to 90 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 87 studies in Stroke by VA Office of Research and Development, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Stroke
  • Brain Disease
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Cardiovascular Diseases
04

Who can participate

Ages eligible
45 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Reaching with TMS

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

    Device: Transcranial Magnetic Stimulation

Interventions

  • DeviceTranscranial Magnetic Stimulation

    Paired pulse transcranial magnetic stimulation

06

What researchers measure

Primary outcomes

  1. Path length

    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 outcomes

  1. Times

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

    Time frame: Immediate (within 2 s after stimulation)

  2. Velocities

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

    Time frame: Immediate (within 2 s after stimulation)

  3. 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.)

    Time frame: Immediate (within 2 s after stimulation)

  4. 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).

    Time frame: Immediate (within 2 s after stimulation)

07

Study locations

1 of 1 sites recruiting
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    Pittsburgh, Pennsylvania 15240, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 12376621 ↗
  • 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. PubMed 15781831 ↗
  • 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. PubMed 28803530 ↗
  • 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. PubMed 8650578 ↗
  • 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. PubMed 12783955 ↗
  • 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. PubMed 16987930 ↗
  • 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. PubMed 16267224 ↗
  • 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. PubMed 27473318 ↗
  • 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. PubMed 8433130 ↗
  • 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. PubMed 16525129 ↗
  • 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. PubMed 8434880 ↗
  • 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. PubMed 28357039 ↗
  • 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. PubMed 41641924 ↗

Individual participant data

Plan to share: No — Research information will not be shared with anyone outside of the research team.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2020 (actual). Primary completion is estimated for Sep 2026, 79 months after the start.

Of 3,111 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 79 months is above that.

Counting every sponsor, half of 3,255 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2020
First posted
Feb 27, 2020
StartActual
Jan 10, 2020
Primary completionEst.
Sep 1, 2026
CompletionEst.
Jun 1, 2027
Last update
Jun 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04286516
Collaborators
VA Pittsburgh Healthcare System, University of Pittsburgh
Responsible party
Sponsor
First posted
Feb 27, 2020
Start date
Jan 10, 2020
Primary completion
Sep 1, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jun 2, 2026

Study contacts

Amy Boos
Contact
amy.boos2@va.gov
(412) 648-4179
George F Wittenberg, MD PhD
Contact
George.Wittenberg@va.gov
(412) 360-6185
George F. Wittenberg, MD PhD
principal investigator · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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