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Trial record 39 of 582 for:    Recruiting, Not yet recruiting, Available Studies | Superior

Priming With tDCS: Expanding the Window of Recovery in Chronic Stroke

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ClinicalTrials.gov Identifier: NCT03964467
Recruitment Status : Recruiting
First Posted : May 27, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborators:
Chapman University
Moss Rehabilitation Research Institute
Thomas Jefferson University
Information provided by (Responsible Party):
Gregory Thielman, University of the Sciences in Philadelphia

Brief Summary:
Stroke often leads to long-term disability including upper extremity (UE) dysfunction even with the provision of timely rehabilitation services. Brain injury stemming from stroke, affecting the corticospinal system results in weakness, alterations in muscle tone and incoordination during the performance of functional tasks. Recovery of functional task performance after injury to the corticospinal system involves a residual neural network that engages the premotor cortex, frontal cortex and supplementary motor cortex. In particular, the dorsal premotor cortex (PMd) is anatomically and physiologically poised to reorganize and support motor recovery after corticospinal damage. The goal of this study is to determine the feasibility and efficacy of stimulating the ipsilesional PMd in adults with chronic stroke using noninvasive anodal transcranial direct current stimulation (tDCS) during the training sessions of a 4-week circuit-based, UE, task-related training (TRT) program. Pilot data from six adults, using anodal tDCS over the injured PMd just before each session of TRT, led to significant improvements in UE function in 5 of the 6 adults after only 4 weeks of training. We will assess the motor function of both arms using clinical assessments immediately before and after the 4-week TRT program. In addition to effects of tDCS-primed UE-TRT on clinical outcomes, we will use functional magnetic resonance imaging (fMRI) to determine the changes in neural network reorganization. We hypothesize that the training program will reveal significant improvement in motor function based on clinical assessment as well as significant global network changes based on resting state functional MRI and hybrid diffusion MR imaging. The long-term goal of this research is to develop an effective intervention strategy to improve UE function in individuals with moderate impairment from chronic stroke.

Condition or disease Intervention/treatment Phase
Upper Extremity Paresis Device: transcranial direct current stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: PI is only doing the testing, while the trainers are training all the participants
Primary Purpose: Treatment
Official Title: Investigation of Central Priming Prior to Training of the Upper Extremity in Chronic Stroke
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Experimental
Transcranial Direct Current Stimulation.1) Scalp measurements of the scalp will be taken using the 10-20 EEG measurement system to determine anode and cathode placement. 2) One 1x1 Bicarbon electrode with wires attached will be placed in the center of each 5 cm x 7 cm sponge electrode dampened with 8 ml of saline. 3) One sponge electrode will be placed over the ipsilesional PMd (F3) and the other sponge electrode over the contralesional supraorbital region(Fp2). 4) Each sponge electrode will be secured under the plastic EZ strap 5) The current from the Actividose II will be turned up to 2 MA. The current will ramp up/down in 15 seconds. We will observe for adverse effects and hit the pause button, then turn the machine off, if a participant does not tolerate the stimulation. Individuals in this arm will have the stimulation stay in current until the full dose is delivered. Each participant will then engage in the UE TRT as outlined below.
Device: transcranial direct current stimulation
see arm/group descriptions
Other Name: Upper extremity Circuit training

Sham Comparator: Control
Individuals in this arm will have the stimulation cycled off after 2-3 minutes. All will be part of the Circuit-Based, UE Task Related Training. Each participant will engage in the training program for 1.5 hours; rotating through 5 stations at about 15 minute intervals, participating in standing as tolerated, but stations can be adapted to sitting. The goal is for each participant perform > 225 movements with the affected arm per session, at the highest functional level. Rest breaks given as needed. Examples of stations are: Reach-to-grasp tasks to objects of various weight, texture and dimension at different distances and table heights. Practice opening simulated locks and containers. Shoulder wheel involving grasping plastic plates with varied grip patterns and sliding them up and over the wheel from the unaffected to the affected side encouraging shoulder abduction, external rotation and supination. Bimanual/unimanual ball toss: catching, releasing.
Device: transcranial direct current stimulation
see arm/group descriptions
Other Name: Upper extremity Circuit training




Primary Outcome Measures :
  1. UE Accelerometry [ Time Frame: 3 day period prior to training ]
    actigraph markers placed on each arm

  2. UE Accelerometry [ Time Frame: 3 day period post training to assess change- more activity inbdicates greater overall use ]
    actigraph markers placed on each arm

  3. Functional MRI [ Time Frame: within 3 days prior to training ]
    fMRI consisting of structural data collected, DTI, resting state data functional task data

  4. Functional MRI [ Time Frame: within 3 days post training to measure change- increased activity in designated areas explains pattern of neuroplasticity ]
    fMRI consisting of structural data collected, DTI, resting state data and functional task data


Secondary Outcome Measures :
  1. Body Structure Function and Impairment Data [ Time Frame: 1-3 days prior to training start ]
    Impairment measures- FMA

  2. Body Structure Function and Impairment Data [ Time Frame: 1-3 days post training ]
    Impairment measures- FMA (19-47. with higher scores indicating positive change)

  3. Body Structure Function and Impairment Data [ Time Frame: 1-3 days prior to training start ]
    Impairment measures- grip strength (0-60 Kg, with higher scores indicating increased strength

  4. Body Structure Function and Impairment Data [ Time Frame: 1-3 days post training ]
    Impairment measures- grip strength

  5. Body Structure Function and Impairment Data [ Time Frame: 1-3 days prior to training start ]
    Impairment measures- AROM

  6. Body Structure Function and Impairment Data [ Time Frame: 1-3 days post training ]
    Impairment measures- AROM (elbow extension- minus 30 to 0, with 0 being full positive for full extension; shoulder flexion- 90 - 180, with greater excursion indicating greater positive progress

  7. Body Structure Function and Impairment Data [ Time Frame: 1-3 days prior to training start ]
    Activity measures-Wolf Motor Function Test- time to complete task

  8. Body Structure Function and Impairment Data [ Time Frame: 1-3 days post training ]
    Activity measures-Wolf Motor Function Test- time to complete task indicated- with less time indicting improvement

  9. Body Structure Function and Impairment Data [ Time Frame: 1-3 days prior to training start ]
    Patient Reported measure- Stroke Impact Scale-

  10. Body Structure Function and Impairment Data [ Time Frame: 1-3 days post training ]
    Patient Reported measure- Stroke Impact Scale- pt.reports changes on named activities participation in real world on a 1-5 point Likert scale across the 8 domains, with higher scores indicating less difficulty on the tasks



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. > 18-75 years of age;
  2. diagnosis of ≥ 1 stroke > 6 months before participation;
  3. in good health;
  4. classified with moderate impairment based on the UE Fugl Meyer Assessment (FMA; score of 19-47
  5. safe for the MRI environment;
  6. able to elevate and hold the paretic arm for 2 seconds at 90 degs shoulder elevation, 160-180O elbow extension and neutral forearm supination;
  7. ≥ 20 degrees gravity minimized wrist extension while holding a cylindrical object on a tabletop.

Exclusion Criteria:

  1. bone or joint limitations that restrict paretic arm motion;
  2. history of skull fractures or burr hole(s);
  3. resting heart rate and resting blood pressure outside the range of 40-100 beats/min and 90/60 to 170/90 mm Hg respectively;
  4. chest pain or shortness of breath at rest;
  5. history epilepsy or seizures;
  6. Botox injections to the paretic arm within 4 months of participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964467


Contacts
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Contact: Gregory T Thielman, EdD 215 596 8680 g.thielm@usciences.edu

Locations
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United States, Pennsylvania
University of the Sciences Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Gregory T Thielman, EdD    215-596-8680    g.thielm@usciences.edu   
Sponsors and Collaborators
University of the Sciences in Philadelphia
Chapman University
Moss Rehabilitation Research Institute
Thomas Jefferson University
Investigators
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Principal Investigator: Gregory Thielman, EdD Professor

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Responsible Party: Gregory Thielman, Professor of Therapy and Neuroscience, University of the Sciences in Philadelphia
ClinicalTrials.gov Identifier: NCT03964467     History of Changes
Other Study ID Numbers: 06-0008
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

all fMRI data will be made available to the ENIGMA Stroke group as a member of this consortium.

The behavioral data is available publicly as able on this or any site I am directed to. Often I am contacted individually by the PI of systematic reviews for this type of data

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: as requested and up to 5 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Gregory Thielman, University of the Sciences in Philadelphia:
stroke
upper extremity
intervention
transcranial direct current stimulation
actigraph
fMRI

Additional relevant MeSH terms:
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Paresis
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms