Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
NCT Number: NCT04166513
This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Milwaukee, Wisconsin, 53226, United States
Aphasia is a disturbance of language, primarily caused by brain injury to the left cerebral hemisphere. Aphasia treatments include speech and language therapy and pharmacologic therapy, but several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits that significantly add to the cost of stroke-related care. Additionally, the amount and frequency of speech and language therapy delivered may have a critical effect on recovery. Therefore, there is a need for new treatments or adjuncts to existing treatments, such as brain stimulation interventions, that have the potential to show greater improvements in patients with aphasia. One such new approach for non-invasive brain stimulation is transcranial direct current stimulation (tDCS).
This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy.
Study design:
Patients will be randomly assigned to one of 2 speech therapy groups in a double-blind, partial crossover design. Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted or active-control anodal-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to either receive the tDCS intervention they did not already receive, within the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the targeted region.
Other names: HD-tDCS, tDCS
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the active control region.
Other names: Active Control tDCS, Active Control HD-tDCS
Participants are asked to generate or choose from a list phonologic information about a target picture.
Other names: Phonologic Component Analysis
Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
Other names: Semantic Feature Analysis
Time frame: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post
Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent correct on lists after each therapy cycle will be the primary behavioral outcome measure (items chosen were at baseline is 0% correct).
There were 20 pictures and 20 words in each of the trained, untrained, and untested lists. Pictures were colored photographs.
Cycle A is the speech therapy intervention given first, Cycle B is the speech therapy intervention given second
Cycle A Trained and Untrained lists were assessed on the last day of therapy for Cycle A Cycle A Post Trained, Untrained and Untested lists were given during Behavioral Assessment 2, approximately 10-weeks post ending Cycle A.
Cycle B Trained and Untrained lists were assessed on the last day of therapy for Cycle B Cycle B Post Trained, Untrained and Untested lists were given during Behavioral Assessment 3, approximately 10-weeks post ending Cycle A.
Time frame: Baseline
Number of participants completing Rs-fMRI before therapy.
Time frame: 10-weeks post Cycle A
Number of participants completing Rs-fMRI after Cycle A therapy.
Time frame: 10 weeks post cycle B
Number of participants completing fMRI post Cycle B
Time frame: 3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B
A language battery screen assessing different language processes and providing an overall severity score (Quick Aphasia Battery or QAB) will be repeated three times (Time 1, Time 2, Time 3). Also outcomes on self-reported measures assessing confidence with speaking: Communicative Effectiveness Index (CETI), Communication Confidence Rating Scale for Aphasia (CCRSA) and overall symptoms of depression; Center for Epidemiologic Studies Short Depression Scale (CES-D-10).
QAB = Total score range 0-10, higher scores mean less severe aphasia severity CETI= Total score range 1-100, higher scores mean better perceived communication confidence by an outside rater CCRSA = Total score range 0-100, higher scores mean more confidence in speaking ability CES-D-10= Total score range 0-30, scores >10 indicate symptoms of depression
Medical College of Wisconsin
Other
Effects of tDCS in Language Recovery and Reorganization in Chronic Aphasia
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