Clinical trial NCT04364854: Speech Entrainment for Aphasia Recovery
Official title: Speech Entrainment for Aphasia Recovery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Aphasia
Aphasia Non Fluent
Stroke
Keywords: Aphasia
Speech Language Pathology
Therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2020-04-28
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After a stroke, many people experience a language impairment called aphasia. One of the most debilitating types of aphasia is non-fluent aphasia. Non-fluent aphasia is defined by significantly reduced speech production, with the speaker producing only a few words or even less. Speech entrainment therapy (SET) is a treatment that has been shown to increase fluency in people with non-fluent aphasia. The study looks to define the best dose of SET that leads to sustained improvements in spontaneous speech production.

Participants who are eligible will undergo baseline language testing, an MRI, and will be randomized into one of 4 treatment groups: SET for 3 weeks, SET for 4.5 weeks, SET for 6 weeks, and no treatment (control group).


Eligibility criteria: Inclusion Criteria

* Aphasia as a result of a left hemisphere ischemic or hemorrhagic stroke (WAB-R Aphasia Quotient \<93.8).
* Presence of left hemisphere stroke in clinical imaging (CT/MRI) and NIHSS
* Participants must have spoken English as their primary language.
* 21-81 years old
* Pre-stroke modified Rankin Scale (mRS)= 2 or less
* Post-stroke mRS= 4 or less.
* At least 6 months post-stroke.
* Non-fluent aphasia (WAB-R Comprehension score \>4 and WAB-R Fluency score \<6).
* Technological compatibility (to be determined by clinical judgment of SLP)

Exclusion Criteria

* History of chronic neurological or psychiatric diseases (excluding migraines, depression, or post-stroke epilepsy). Self-reported history of learning disability.
* Severe dysarthria (determined via SLP clinical judgment from spontaneous speech tasks on the ASRS 3.0).
* Global aphasia.
* History of right-hemisphere strokes or brain stem/cerebellar strokes with persistent deficits (as evidenced by MRI/CT and NIHSS).
* Uncorrectable hearing as determined by the SLP's clinical judgment.
* Uncorrectable vision.
* Contraindications to MRI or inability to complete the MRI scanning session.
* Women who are pregnant.

Primary outcomes:
measure: Average Verbs Per Minute (VPM) Change From Baseline
timeFrame: 3 months after treatment (or no treatment)
Secondary outcomes:
measure: Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline
timeFrame: 3 months after treatment (or no treatment)
measure: Narrative Verbs Per Minute (VPM)
timeFrame: 3 months after treatment (or no treatment)
measure: Procedural Verbs Per Minute (VPM) Change From Baseline
timeFrame: 3 months after treatment (or no treatment)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Emory University
name: Leonardo Bonilha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: