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tDCS to Treat Subacute Aphasia

Primary Purpose

Aphasia, Stroke, Acute

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring non-invasive brain stimulation, tDCS

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Presence of aphasia attributable to stroke that occurred between 7 days and 3 months (inclusive) prior to inclusion in the study.
  • 2. Must be able to understand the nature of the study, and give informed consent.
  • 3. 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
  • 2. Current unstable medical illness(es)
  • 3. History of reoccurring seizures or epilepsy
  • 4. Current abuse of alcohol or drugs
  • 5. Active or History of major psychiatric disorder
  • 6. Pregnancy
  • 7. Subjects with metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.

Sites / Locations

  • Penn Institute for Rehabilitation Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Anodal tDCS

Sham tDCS

Arm Description

2mA for 20 minutes

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

Outcomes

Primary Outcome Measures

Change in Aphasia Severity
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".

Secondary Outcome Measures

Full Information

First Posted
August 5, 2019
Last Updated
September 18, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04048668
Brief Title
tDCS to Treat Subacute Aphasia
Official Title
Transcranial Direct Current Stimulation to Enhance Language Recovery in Patients With Aphasia After Subacute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
Suspended due to COVID-19
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke, Acute
Keywords
non-invasive brain stimulation, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS
Arm Type
Active Comparator
Arm Description
2mA for 20 minutes
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
30 second ramp-up / ramp-down for 20 minutes
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
Standard of Care Speech Therapy
Intervention Description
tDCS is a non-invasive brain stimulation technique by which very small electrical currents (2 mA) are applied to the scalp.
Primary Outcome Measure Information:
Title
Change in Aphasia Severity
Description
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".
Time Frame
Baseline, Immediate Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Presence of aphasia attributable to stroke that occurred between 7 days and 3 months (inclusive) prior to inclusion in the study. 2. Must be able to understand the nature of the study, and give informed consent. 3. 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 2. Current unstable medical illness(es) 3. History of reoccurring seizures or epilepsy 4. Current abuse of alcohol or drugs 5. Active or History of major psychiatric disorder 6. Pregnancy 7. Subjects with metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.
Facility Information:
Facility Name
Penn Institute for Rehabilitation Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States

12. IPD Sharing Statement

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tDCS to Treat Subacute Aphasia

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