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

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Recruiting
CT.gov ID
NCT06048159
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
112
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: HD-tACS
  • Device: Sham HD-tACS
 N/A

Detailed Description

Aphasia is a debilitating disorder, typically resulting from damage to the left hemisphere, that can impair a range of communication abilities, including language production and comprehension, reading, and writing. Approximately 180,000 new cases of aphasia are identified per year, and approximately 1 million or 1 in 250 are living with aphasia in the United States. Treatments are limited and provide modest benefits at best. The current emphasis in aphasia rehabilitation is to formulate intensive speech and language therapies and augment therapeutic benefits, potentially with brain stimulation concurrent with therapies.

The current study will investigate the efficacy of high-definition tACS (HD-tACS) to help restore neural oscillatory activity in stroke survivors with aphasia. TACS differs from trancranial direct current stimulation (tDCS), a widely used brain stimulation paradigm, in that sinusoidal or alternating currents are delivered rather than direct currents. TACS is shown to manipulate ongoing oscillatory brain activity and also to modulate synchronization (or connectivity) between targeted brain areas. This feature of tACS is quite attractive, given the new body of evidence suggesting that language impairments stem from diminished brain connectivity and ensuing disruptions in the language network due to stroke.

The study will employ high-definition tACS (HD-tACS) in a parallel, double-blinded, sham-controlled design combined with language therapy targeting phonological short-term memory (STM) function in stroke survivors with aphasia. Magnetoencephalography (MEG) and fMRI BOLD data collection will occur to determine tACS parameters and to evaluate stimulation-induced neural changes, respectively. The investigators plan to recruit 120 stroke survivors with aphasia in a 2-group tACS study design.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
TACS for the Recovery of Phonological STM After Stroke
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2033
Anticipated Study Completion Date :
Jan 1, 2033

Arms and Interventions

Arm Intervention/Treatment
Experimental: High Definition tACS with Short-term Memory Focused Speech Therapy

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
High definition tACS will be applied during speech therapy.
Sham Comparator: Sham-High Definition tACS with Short-term Memory Focused Speech Therapy

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
Sham high definition tACS will be applied during speech therapy.

Outcome Measures

Primary Outcome Measures

  1. Accuracy on a phonological STM task [Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post]

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

  2. fMRI measures of language network activation after tACS [Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post]

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

Secondary Outcome Measures

  1. Functional Communication Outcome [Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post]

    Improvements in using language in daily life or functional communication as assessed by patient reported measure of Communication Effectiveness Index (CETI)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosed with left hemisphere stroke/aphasia

  • Consent date >= 1 month after stroke onset

  • Fluent in English

  • 18 years of age or older

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Medical College of Wisconsin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Priyanka Shah-Basak, PhD, Principal Investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT06048159
Other Study ID Numbers:
  • PRO00046360
  • PRO00046360
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Stroke
Aphasia

Study Results

No Results Posted as of Sep 21, 2023