Transcranial Alternating Current Stimulation (tACS) for the Recovery of Phonological Short-Term Memory in Patients With Aphasia After Stroke

NCT06048159 | Recruiting FDA Device

• 1 other identifier: PRO00046360
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke.

Conditions

Stroke; Aphasia

Outcome Measures

Primary Outcomes (2)

• Accuracy on a phonological STM task

  Accuracy changes in a delayed sample-to-match task assessing phonological STM after tACS.

  Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post

• fMRI measures of language network activation after tACS

  Activation in the language network regions involved in phonological STM will be assessed before and after tACS

  Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post

Secondary Outcomes (1)

• Functional Communication Outcome

  Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post

Study Arms (2)

High Definition tACS with Short-term Memory Focused Speech Therapy

EXPERIMENTAL

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages.The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS stimulation for 20-minutes with 2 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes. This will be paired with short-term memory focused speech therapy.

Device: HD-tACS

Sham-High Definition tACS with Short-term Memory Focused Speech Therapy

SHAM COMPARATOR

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the active tACS groups. This will be paired with short-term memory focused speech therapy.

Device: Sham HD-tACS

Interventions

HD-tACS DEVICE

High definition tACS will be applied during speech therapy.

High Definition tACS with Short-term Memory Focused Speech Therapy

Sham HD-tACS DEVICE

Sham high definition tACS will be applied during speech therapy.

Sham-High Definition tACS with Short-term Memory Focused Speech Therapy

Eligibility Criteria

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

You may qualify if:

• Diagnosed with left hemisphere stroke/aphasia
• Consent date \>= 1 month after stroke onset
• Fluent in English
• years of age or older

You may not qualify if:

• Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
• Presence of major untreated or unstable psychiatric disease
• A chronic medical condition that is not treated or is unstable
• The presence of cardiac stimulators or pacemakers
• Contraindications to MRI or tACS, e.g. patients with metallic implants, and/or history of skull fractures, pregnancy, skin diseases
• History of ongoing or unmanaged seizures
• History of dyslexia or other developmental learning disabilities

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (52)

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• National Aphasia Association survey. (2020).

  BACKGROUND

MeSH Terms

Conditions

Stroke; Aphasia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sidney E Schoenrock, MA

CONTACT

414-955-7579; sschoenrock@mcw.edu

Priyanka Shah-Basak, PhD

CONTACT

414-955-5752; prishah@mcw.edu

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 21, 2023
• Study Start: November 6, 2023
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)