NCT04308629

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

March 3, 2020

Last Update Submit

March 11, 2020

Conditions

Keywords

StartReact responsetranscranial direct current stimulationPostural control

Outcome Measures

Primary Outcomes (2)

  • Change in startReact response

    The incidence of StartReact response following an loud acoustic stimulus

    Immediately after the intervention (one session tDCS)

  • 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)

    Immediately after the intervention (one session tDCS)

Secondary Outcomes (6)

  • Change in the reach onset (unit: seconds)

    Immediately after the intervention (one session tDCS)

  • Change in the APA onset (unit: seconds)

    Immediately after the intervention (one session tDCS)

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

    Immediately after the intervention(one session tDCS)

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

    Immediately after the intervention (one session tDCS)

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

    Immediately after the intervention (one session tDCS)

  • +1 more secondary outcomes

Study Arms (2)

tDCS over PMAs

EXPERIMENTAL

One session of transcranial direct current stimulation (tDCS) over premotor areas (PMAs)

Other: Transcranial direct current stimulation

tDCS over M1

ACTIVE COMPARATOR

One session of transcranial direct current stimulation (tDCS) over primary motor area (M1)

Other: Transcranial direct current stimulation

Interventions

tDCS over M1tDCS over PMAs

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

StrokeParesis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 16, 2020

Study Start

October 1, 2016

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

March 16, 2020

Record last verified: 2020-02