Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 45 for:    NOT MRI NOT Imaging NOT intensive NOT auditory NOT thermal NOT mirror NOT TENS NOT tactile NOT motion NOT Passy NOT music NOT flow NOT vibration NOT fluid NOT ASIS NOT traditional | Recruiting, Not yet recruiting, Available Studies | Stroke | Deep Brain Stimulation OR magnetic OR transcranial direct current

Improving Measurement and Treatment of Post-stroke Neglect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03317860
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This study examines how to best assess and treat post-stroke neglect. This study will examine the preliminary effects of an innovative intervention (repetitive task-specific practice + transcranial direct current stimulation) for individuals with neglect. This study will also determine whether items from various neglect assessments can be combined to establish a more comprehensive neglect measure.

Condition or disease Intervention/treatment Phase
Stroke Device: Sham tDCS Device: Active tDCS Not Applicable

Detailed Description:
It is very common for stroke survivors to have difficulty attending to one side of their body or space (neglect). Stroke survivors with neglect not only demonstrate impairments in attention but they also experience motor impairment. These individuals also have an imbalance in excitation in the brain. This study will examine the preliminary effects of non-invasive brain stimulation (transcranial direct current stimulation, tDCS) combined with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with neglect following stroke. The investigators will examine the effects of the intervention on brain excitability, upper extremity motor impairment, and attentional impairment. This study will also examine assessment of neglect. There are many clinical assessments designed to assess neglect; however, it is unknown whether items from some of the most commonly used assessments are able to effectively measure neglect or whether items from these assessments can be combined. Clinicians rely on clinical assessments to inform treatment and document patient progress. Therefore, it is important that investigators more closely examine these existing assessments.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants will receive both conditions (active and sham transcranial direct current stimulation paired with arm rehabilitation training [repetitive task-specific practice]) in this cross-over design study. Individuals will be randomized to determine which condition they receive first and the participant and treatment therapist and assessor will be blinded to the order that the interventions are delivered. The PI will oversee randomization so that each patient is randomized and assigned a unique five digit code. When this code is entered on the tDCS device, the device will automatically assign the patient to receive either real or sham stimulation. Because the sham stimulation provides a ramp up/ramp down stimulation for 15 seconds at the start and end of the session the participant may perceive the sham stimulation as active stimulation.
Primary Purpose: Other
Official Title: Improving Measurement and Treatment of Post-stroke Neglect
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : July 3, 2023
Estimated Study Completion Date : July 3, 2023

Arm Intervention/treatment
Sham Comparator: Sham tDCS plus RTP
Single session of bilateral sham parietal cortex tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)
Device: Sham tDCS

Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.

Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete functional movements during the 30 minute train

Other Name: noninvasive brain stimulation, transcranial direct current stimulation

Active Comparator: Active tDCS plus RTP
Single session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)
Device: Active tDCS

Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.

Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete functional movements during the 30 minute train

Other Name: noninvasive brain stimulation, transcranial direct current stimulation




Primary Outcome Measures :
  1. Change in excitability of fronto-parietal connectivity [ Time Frame: Participants will be assessed at baseline and 30 minutes later ]
    Excitability of fronto-parietal connectivity measured by paired pulse twin coil transcranial magnetic stimulation (TMS) test. In each session, the difference in excitability of fronto-parietal connectivity between pre and post stimulation will be measured.


Secondary Outcome Measures :
  1. Change in upper extremity kinematics [ Time Frame: Participants will be assessed at baseline and 30 minutes later ]
    A kinematic assessment will be conducted to assess changes in motor impairment.

  2. Change on Behavioral Inattention Test [ Time Frame: Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition) ]
    A neglect assessment (conventional subtests) will be conducted to assess changes in attentional impairment. Total scores range from 0-146 with lower scores indicating greater impairment.


Other Outcome Measures:
  1. Catherine Bergego Scale [ Time Frame: Participants in the cross-sectional study will be assessed at baseline. ]
    This neglect assessment will be administered to examine the impact of neglect on performance of daily activities. Total scores range from 0-30 with higher scores indicating greater impairment.

  2. Behavioral Inattention Test [ Time Frame: Participants in the cross-sectional study will be assessed at baseline. ]
    This neglect assessment (behavioral subtests) will be administered to examine the impact of neglect on performance of daily activities. Total scores range from 0-81 with lower scores indicating greater impairment.

  3. Naturalistic Action Test [ Time Frame: Participants in the cross-sectional study will be assessed at baseline. ]
    This neglect assessment will be administered to examine the impact of neglect on performance of daily activities. Each item has a score of 0-6 with lower scores indicating greater impairment. The Lateralized Attention Score (LAS) is difference between the contralateral and ipsilateral proportion of items. Higher LAS scores indicate greater impairment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Right ischemic or hemorrhagic subcortical stroke 3 months post stroke.
  • Fugl-Meyer Upper Extremity (FMA-Upper Extremity) score between 20-56/60
  • Inducible motor evoked potential (MEP) of the abductor pollicis brevis (APB) on the paretic stimulation (TMS)
  • Demonstrate the presence of unilateral neglect (Virtual Reality Lateralized Attention Test score <18)

Exclusion Criteria:

  • History of cortical hemorrhagic stroke
  • Presence of any MRI, TMS, tDCS risk factors including:

    • history of seizures
    • history of brain tumor
    • hardware in skull or spine (e.g. coils, clips)
    • implantable medical device (e.g. pacemaker)
    • metal in body (not compatible with MRI)
    • pregnancy
  • Severe spasticity (Modified Ashworth Scale score 3)
  • Severe aphasia or cognitive impairment limiting participants' comprehension (National Institutes of Health Stroke Scale Level of Consciousness Commands Item score 1 or Best Language Item score 2)
  • Unable to travel to UE Motor Function Laboratory at the Center for Rehabilitation Research in Neurological Conditions (a collaborative, MOU approved, research center Ralph H. Johnson VA Medical Center and the Medical University of South Carolina) for the study

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): NCT03317860


Contacts
Layout table for location contacts
Contact: Emily S Grattan, PhD OTR MS (843) 792-3435 grattan@musc.edu
Contact: Michelle L Woodbury, PhD (834) 792-1671 WoodbuML@musc.edu

Locations
Layout table for location information
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC Recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Emily S Grattan, PhD OTR MS    843-792-3435    grattan@musc.edu   
Principal Investigator: Emily S. Grattan, PhD OTR MS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Emily S. Grattan, PhD OTR MS Ralph H. Johnson VA Medical Center, Charleston, SC

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03317860     History of Changes
Other Study ID Numbers: N2420-W
1IK2RX002420-01A2 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
perceptual disorders
cerebrovascular disorders
neurobehavioral manifestations
neurologic manifestations
neglect
non-invasive brain stimulation
rehabilitation
tDCS
paresis
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases