tDCS to Treat Subacute Aphasia

NCT04048668 | Withdrawn

• 1 other identifier: 813736
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Stroke, Acute

Keywords

non-invasive brain stimulation; tDCS

Outcome Measures

Primary Outcomes (1)

• 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".

  Baseline, Immediate Follow-up

Study Arms (2)

Anodal tDCS

ACTIVE COMPARATOR

2mA for 20 minutes

Device: Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

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

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

tDCS is a non-invasive brain stimulation technique by which very small electrical currents (2 mA) are applied to the scalp.

Also known as: Standard of Care Speech Therapy

Anodal tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Must be able to understand the nature of the study, and give informed consent.
• \. English must be their native language where "native" is defined as learning English before the age of 6

You may not qualify if:

• \. History of chronic, serious, or unstable neurologic illness(es) other than stroke
• \. Current unstable medical illness(es)
• \. History of reoccurring seizures or epilepsy
• \. Current abuse of alcohol or drugs
• \. Active or History of major psychiatric disorder
• \. Pregnancy
• \. Subjects with metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Institute for Rehabilitation Medicine

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 7, 2019
• Study Start: September 1, 2019
• Primary Completion: July 15, 2022
• Study Completion: July 1, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

US (1)