Brain Correlates of Multimodal Rehabilitation in Chronic Post-stroke Aphasia

• Status: Completed
• Trial end date: 2020-10-20
• Target enrollment: 0
• Participant gender: All

Summary

Post-stroke aphasia (PSA), the partial or total loss of the ability to produce and/or understand language associated with stroke, is a highly prevalent and disabling disorder that negatively impacts the personal, social and working life of patients and families. Modern theory-based language therapies (LT) with proved efficacy in chronic PSA are brief (weeks), intensive, and oriented to specific domains (e.g., anomia). However, in order to maximize therapeutic benefits, it becomes essential to implement complementary strategies that boost gains in language, communication and behaviour and also to identify predictors of treatment response (demographics, anatomical) that enable to customize interventions adjusting them to each profile (linguistic deficits, brain structure and connectivity). Our group has repeatedly shown that LT combined with cognitive enhancing drugs (CED) (e.g., Donepezil and Memantine) are safe and promote better outcomes that when these interventions are administered separately. Moreover, non-invasive brain stimulation techniques (NIBS), such as transcranial direct current stimulation (tDCS), are also emerging as a promising treatment option for chronic PSA. However, is still unknown whether or not treatments that combine several biological strategies aid to improve outcomes further. Brain changes induced by these interventions and the premorbid characteristic of a "good responder" are also unknown. The aims of this clinical trial are: (1) Study the efficacy of combined treatments in a sample of patients with chronic PSA (n = 40); (2) Document with multimodal neuroimaging the functional and connectivity changes (neuroplasticity) promoted by these interventions; and (3) Identify linguistic, cognitive and behavioural variables that may predict outcomes for each intervention.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Malaga
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• Age between 18 and 70 years

• Right handedness (80 point in the Edinburgh Handedness Inventory)

• Spanish as native language

• Single left-hemisphere stroke

• Diagnosis of aphasia established by a score in the Aphasia Quotient of the Spanish version of the Western Aphasia Battery (WAB) < 93.8 points.

Exclusion Criteria:

• Dysarthria without aphasia

• Multiple or bilateral injuries

• Increased risk of a new stroke or unstable neurological condition (e.g. transient ischemic attacks)

• History of severe psychiatric illness (schizophrenia, major depression, bipolar disorder, anxiety disorders)

• Alcohol and substance use or abuse

• Coexistence of aphasia with dementia.