tDCS to Treat Subacute Aphasia

Sponsor
University of Pennsylvania (Other)
Overall Status
Suspended
CT.gov ID
NCT04048668
Collaborator
(none)
30
1
2
35
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Study Details

Study Description

Brief Summary

This study proposes to use transcranial direct current stimulation (tDCS), a technique by which a very small electrical current (2 mA) is applied to the scalp, along side speech therapy in patients with subacute stroke and aphasia in order to enhance language recovery. Aphasic patients in an inpatient neurorehabilitation facility who have experienced a stroke between one week and three months prior to enrollment will be invited to participate. Participants will receive either real or sham tDCS to the left hemisphere of the brain for a minimum of 5 consecutive sessions to up-to a max of 10 sessions depending on the length of their rehab stay . Stimulation will be paired with with the patient's normal speech therapy schedule. Participant's language skills will be assessed at baseline and immediately after the last session of therapy in order to determine whether tDCS is associated with either transient or persistent improvement in language.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Direct Current Stimulation (tDCS)
N/A

Detailed Description

Speech therapy is the standard of care nationwide in treating individuals who have had a stroke and are now experiencing aphasia. Speech therapy can help to rehabilitate language skills and supplement function by teaching alternate strategies for communication; however, these benefits often leave room for further improvement. Researchers have focused their efforts in combining speech therapy with other techniques to boost the effects. In this study, we will combine speech therapy with non-invasive brain stimulation, specifically transcranial direct current stimulation (tDCS), in the hopes of significantly improve language in subacute aphasia patients.

This is a double-blind, randomized, sham-controlled pilot project, where inpatients with subacute stroke and aphasia will be recruited from the Penn Institute for Rehabilitation Medicine hospital (PIRM). The typical patient admitted to PIRM is approximately 1-2 weeks post-stroke. Upon enrollment, baseline aphasia severity will be characterized using standardized measures such as the Western Aphasia Battery (WAB), Pyramids and Palm Trees (PPT) and Philadelphia Naming Test (PNT) by the patient's speech therapist. Subjects will subsequently be randomized to undergo either real or sham tDCS. Subjects will then undergo a minimum of 5-consectuive stimulation session (Monday-Friday) and maximum of 10-consecutive stimulation sessions (Monday-Friday) of either real or sham tDCS. During stimulation, subjects will receive either real tDCS at a current of 2.0 mA for 20 minutes or sham stimulation for an equivalent period of time with a 30sec ramp-up/ramp-down. Sham stimulation mimics real stimulation closely; most subjects cannot distinguish between real and sham tDCS. During stimulation visits subjects will concurrently participate in their regular speech therapy treatment. Speech Therapy will be administered by their speech therapist and will follow whatever protocol the therapist deems useful for standard of care treatment of their aphasia. An immediate follow-up session will also take place, subjects will repeat language batteries including the WAB, PPT and PNT.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Transcranial Direct Current Stimulation to Enhance Language Recovery in Patients With Aphasia After Subacute Stroke
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anodal tDCS

2mA for 20 minutes

Device: Transcranial Direct Current Stimulation (tDCS)
tDCS is a non-invasive brain stimulation technique by which very small electrical currents (2 mA) are applied to the scalp.
Other Names:
  • Standard of Care Speech Therapy
  • Sham Comparator: Sham tDCS

    30 second ramp-up / ramp-down for 20 minutes

    Device: Transcranial Direct Current Stimulation (tDCS)
    tDCS is a non-invasive brain stimulation technique by which very small electrical currents (2 mA) are applied to the scalp.
    Other Names:
  • Standard of Care Speech Therapy
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Aphasia Severity [Baseline, Immediate Follow-up]

      Measured by WAB AQ score. A higher score indicated better language function. Scores can range from 0-100 with any score over 93 considered "recovered".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Presence of aphasia attributable to stroke that occurred between 7 days and 3 months (inclusive) prior to inclusion in the study.
      1. Must be able to understand the nature of the study, and give informed consent.
      1. English must be their native language where "native" is defined as learning English before the age of 6
    Exclusion Criteria:
      1. History of chronic, serious, or unstable neurologic illness(es) other than stroke
      1. Current unstable medical illness(es)
      1. History of reoccurring seizures or epilepsy
      1. Current abuse of alcohol or drugs
      1. Active or History of major psychiatric disorder
      1. Pregnancy
      1. Subjects with metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Penn Institute for Rehabilitation Medicine Philadelphia Pennsylvania United States 19146

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT04048668
    Other Study ID Numbers:
    • 813736
    First Posted:
    Aug 7, 2019
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Pennsylvania
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021