TACS for the Recovery of Phonological STM After Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Accuracy on a phonological STM task
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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: HD-tACS (Device)
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: Sham HD-tACS (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Functional Communication Outcome(Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post)
Investigators
Priyanka Shah-Basak, PhD
Principal Investigator
Medical College of Wisconsin