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StrokeNCT04308629

Cortical Enhancement of Posture, Movement Planning, and Execution of Upright Reaching Following Stroke

A study testing Transcranial direct current stimulation in people with Stroke and Upper Extremity Paresis, run by University of Maryland, Baltimore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke is the leading cause of disability and diminished quality of living that frequently includes impairments of postural control and upper extremity (UE) function. The interaction of posture and UE coupling in terms of movement planning, initiation, and execution is not well understood. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke, Upper Extremity Paresis
What is being tested?
Transcranial direct current stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
1 Oct 2016to 30 Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Unilateral cortical or white matter subcortical stroke
  • Age 40 yrs and older
  • ≥ 6 months post ischemic stroke or ≥ 12 months post hemorrhagic stroke
  • Residual arm hemiparesis as indicated by Fugl-Meyer Upper Extremity score between 20-65
  • Having the ability to perform reaching movements with the paretic arm in standing without an assistive device.
  • Age-matched to the stroke subjects
  • Without a history of stroke or any known neurological conditions
  • Having the cognitive ability to follow two-step commands and give informed consent

Who cannot join

  • Stroke involving bilateral hemisphere, brainstem or cerebellum
  • Any medical condition precluding participation in testing
  • Other health conditions affecting balance and upper extremity movement function beyond the effects of stroke.
  • Any medical condition precluding participation in testing
  • Other health conditions affecting balance and upper extremity movement function beyond the effects of stroke.
  • Participants were also excluded if they did not meet the TMS safety criterion including having implantable medical devices, history of seizures, taking medications to reduce anxiety, sedatives, and seizure, and pregnancy.

About this study

Stroke is the leading cause of disability and diminished quality of living that frequently includes impairments of postural control and upper extremity (UE) function. The interaction of posture and UE coupling in terms of movement planning, initiation, and execution is not well understood. StartReact responses triggered by a loud acoustic stimulus (LAS) during the planning and preparation of goal intended actions has been used to probe the state of brainstem neuronal excitability related to posture and movement sequencing. The purpose of this study is to examine posture and goal-directed movement planning and execution using startReact responses and to evaluate posture and UE movement sequence during reaching while standing in individuals with chronic hemiparesis and healthy controls. Secondly, the investigators will determine the modulatory role of the cortical premotor areas (PMAs) in startReact responses in healthy controls and in persons with stroke by using transcranial direct current stimulation (tDCS) to up- or down-regulate PMAs excitability.

Keywords
StartReact response, transcranial direct current stimulation, Postural control
Medical subject headings
Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04308629
Study groupRoleWhat they receive
tDCS over PMAsExperimentalOne session of transcranial direct current stimulation (tDCS) over premotor areas (PMAs)
Receives: Other: Transcranial direct current stimulation
tDCS over M1Active comparatorOne session of transcranial direct current stimulation (tDCS) over primary motor area (M1)
Receives: Other: Transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in startReact response

    The incidence of StartReact response following an loud acoustic stimulus

    Measured: Immediately after the intervention (one session tDCS)

  2. Change in the lag between anticipatory postural adjustments and reach onset

    The temporal lag between anticipatory postural adjustments (APA) onset and reach onset (unit: seconds)

    Measured: Immediately after the intervention (one session tDCS)

Secondary outcomes (6)

  1. Change in the reach onset (unit: seconds)

    The onset of the anterior wrist joint center movement with a threshold of 5% peak velocity

    Measured: Immediately after the intervention (one session tDCS)

  2. Change in the APA onset (unit: seconds)

    The onset of the posterior center of pressure displacement with a threshold of 5% peak velocity

    Measured: Immediately after the intervention (one session tDCS)

  3. Change in the amount of trunk flexion (unit: radians)

    The angular displacement of the line joining the reaching shoulder and the hip joint center on the same side in the sagittal plane at maximum reach normalized by reach distance

    Measured: Immediately after the intervention(one session tDCS)

  4. Change in the amount of trunk rotation (unit: radians)

    The angular displacement of the line connecting both shoulders in the horizontal plane in the direction of the reach at maximum reach normalized by reach distance

    Measured: Immediately after the intervention (one session tDCS)

  5. Change in the amount of pelvic rotation (unit: radians)

    The angular displacement of the line connecting both hip joint centers in the horizontal plane in the direction of the reach at maximum reach normalized by reach distance

    Measured: Immediately after the intervention (one session tDCS)

  6. Change in the amount of trunk-pelvic rotation difference (unit: radians)

    The difference between trunk and pelvic angular displacement at maximum reach normalized by reach distance

    Measured: Immediately after the intervention (one session tDCS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2020
  2. Study start1 Oct 2016
  3. Primary completion30 Oct 2017
  4. Study completion30 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04308629
Sponsor's protocol ID
HP-00064894
Status last verified
Feb 2020
First submitted
3 Mar 2020
Last updated
16 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yang CL, Gad A, Creath RA, Magder L, Rogers MW, Waller SM. Effects of transcranial direct current stimulation (tDCS) on posture, movement planning, and execution during standing voluntary reach following stroke. J Neuroeng Rehabil. 2021 Jan 7;18(1):5. doi: 10.1186/s12984-020-00799-8.

    PubMed 33413441

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation in people with Stroke and Upper Extremity Paresis, run by University of Maryland, Baltimore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in startReact response (time frame: Immediately after the intervention (one session tDCS)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04308629, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.

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