Clinical trial NCT03699930: Impact of Neuromodulation on Language Impairments in Stroke Patients
Official title: Impact of Neuromodulation on Language Impairments in Stroke Patients: a Multimodal Double-blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aphasia
Keywords: transcranial direct current stimulation
stroke
aphasia
speech therapy
neurorehabilitation
neuromodulation
language function
neuroplasticity
neuroimaging
EEG
MRI
genetics
language disorders
Lead sponsor: Casa Colina Hospital and Centers for Healthcare
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind quasi-randomized controlled design
Primary purpose: TREATMENT

Brief summary: Up to 40% of stroke survivors suffer from aphasia, making recovery of language abilities a top priority in stroke rehabilitation. Conventional speech and language therapy may have limited effectiveness. Leveraging multimodal data (behavioral, neuroimaging, and genetics), this study aims to 1) evaluate the efficacy of combining tDCS with speech therapy, 2) examine neural changes associated with recovery, 3) identify factors influencing response to treatment.

Detailed description: Approximately one million people in the United States are living with aphasia, an acquired neurological disorder affecting the ability to use and/or understand language. This communication impairment affects up to 40% of stroke patients. Stroke victims usually prioritize speaking, writing, and walking as the three most important rehabilitation goals, two of these goals therefore involving communication. Conventional speech therapy strategies have nevertheless limited effectiveness in post-stroke aphasia. Indeed, approximately half of those affected will remain in this state despite intensive speech therapy. Effective novel treatment is therefore warranted to improve recovery in these patients. Recent evidence suggests that transcranial direct current stimulation (tDCS), a non-invasive, low-cost neuromodulation technique, applied in conjunction with speech therapy may be more effective in promoting language recovery than behavioral intervention alone.

A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke aphasics. Participants will be assigned to either the tDCS group or to the sham (placebo) group and will receive 20 minutes of concurrent speech and language therapy by a trained speech therapist over five consecutive days. Behavioral, EEG, and MRI data will be acquired within one week before and after intervention. Genetic samples will be collected once. Secondary behavioral outcome measures will be performed again 3 months following tDCS/sham intervention to assess long-term benefits.

Eligibility criteria: Inclusion Criteria:

* Between ages 18-85
* At least 12 months post stroke
* Diagnosed with aphasia due to ischemic or hemorrhagic stroke
* English speaking
* Right handed prior to stroke

Exclusion Criteria:

* Nonverbal
* Other neurological diseases/disorders
* Not MRI-compatible (e.g. claustrophobia, metal implants in the head)

Primary outcomes:
measure: Change in Western Aphasia Battery-Revised scores
timeFrame: At baseline and at week 3
Secondary outcomes:
measure: Change in Magnetic Resonance Imaging (MRI)
timeFrame: At baseline and at week 3
measure: Change in resting state Electroencephalograph (EEG) signals
timeFrame: At baseline and at week 3
measure: Change in Test of Nonverbal Intelligence (TONI-4)
timeFrame: At baseline and at week 3
measure: Change in Communication Outcomes after Stroke (COAST)
timeFrame: At baseline, at week 3, and at week 17
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: At baseline, at week 3, and at week 17
measure: Change in Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
timeFrame: At baseline, at week 3, and at week 17
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Casa Colina Hospital and Centers for Healthcare
state: California
Study officials:
affiliation: Casa Colina Hospital and Centers for Healthcare
name: Amy Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: