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

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ClinicalTrials.gov Identifier: NCT06048159
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
Priyanka Shah-Basak, PhD, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE August 18, 2023
First Posted Date  ICMJE September 21, 2023
Last Update Posted Date March 13, 2024
Actual Study Start Date  ICMJE November 6, 2023
Estimated Primary Completion Date January 2033   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2023)
  • Accuracy on a phonological STM task [ Time Frame: 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.
  • fMRI measures of language network activation after tACS [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2023)		 Functional Communication Outcome [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Alternating Current Stimulation (tACS) for the Recovery of Phonological Short-Term Memory in Patients With Aphasia After Stroke
Official Title  ICMJE TACS for the Recovery of Phonological STM After Stroke
Brief Summary This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Aphasia
Intervention  ICMJE
  • Device: HD-tACS
    High definition tACS will be applied during speech therapy.
  • Device: Sham HD-tACS
    Sham high definition tACS will be applied during speech therapy.
Study Arms  ICMJE
  • 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.
    Intervention: Device: HD-tACS
  • 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.
    Intervention: Device: Sham HD-tACS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2023)		 120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2033
Estimated Primary Completion Date January 2033   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sidney E Schoenrock, MA 414-955-7579 sschoenrock@mcw.edu
Contact: Priyanka Shah-Basak, PhD 414-955-5752 prishah@mcw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06048159
Other Study ID Numbers  ICMJE PRO00046360
PRO00046360 ( Other Identifier: Medical College of Wisconsin )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Priyanka Shah-Basak, PhD, Medical College of Wisconsin
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medical College of Wisconsin
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical College of Wisconsin
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP