tDCS to Treat Subacute Aphasia

August 6, 2024 updated by: University of Pennsylvania

Transcranial Direct Current Stimulation to Enhance Language Recovery in Patients With Aphasia After Subacute Stroke

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Penn Institute for Rehabilitation Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Aphasia Severity
Time Frame: 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".
Baseline, Immediate Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 813736

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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