Chronic poststroke aphasia MedDRA version: 20.0 Level: PT Classification code 10002948 Term: Aphasia System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Aricept
Pharmaceutical Form: Tablet
INN or Proposed INN: DONEPEZIL
CAS Number: 120014-06-4
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-10
Sponsors
FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects. 2. Ages between =18 and =70 year old. 3. Right-handed subjects (rank: + 80 + 100 in the Edinburgh Handedness Inventory). 4. Spanish or Catalan as a native language. 5. At least basic education. 6. Having suffered infarctions or single cerebral hemorrhages restricted to the left cerebral hemisphere. 7. Diagnosis of aphasia established by a score in the Aphasia Quotient of the Spanish version of the Western Aphasia Battery (WAB)=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Dysarthria without aphasia. 2. Multiple or bilateral injuries. 3. High risk of suffering a new stroke or unstable neurological condition (eg, transient ischemic attacks). 4. History of severe psychiatric illness (schizophrenia, severe depression, bipolar disorder, anxiety disorders). 5. Use or abuse of alcohol and other substances of abuse. 6. Coexistence of aphasia with dementia. 7. Serious alterations of language (mutism, CV or CVC stereotypes, neologistic jargon, or a score on the WAB Understanding subtest <4). 8. Severe visual agnosia, severe ideomotor/ideational apraxia. 9. Severe speech apraxia where group therapy (REGIAplus) cannot be performed. 10. Pregnancy. 11. Recent myocardial infarction, decompensated cardiac failure, cardiac blocks, bradycardia, uncontrolled arterial hypertension. 12. Epilepsy. 13. Sensitivity to Donepezil or being treated with drugs that interfere with Donepezil (anticholinergics).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the effects of donepezil, Intensive Group Rehabilitation of Aphasia (REGIA) plus (REGIA + repetition / imitation task) and transcranial direct current anodal stimulation (A-tDCS) on the severity of language disorders and associated disorders (communication , behavior, and quality of life) secondary to lesions in the left perisylvian area in patients with chronic post-stroke aphasia.;Secondary Objective: • Evaluate possible changes in cognitive non-linguistic functions (attention, short-term verbal memory and cognitive control) and its relationship with the improvement in the linguistic domain. • Examine, through the use of different neuroimaging techniques, the structural, functional and metabolic changes in the gray and white matter (tracts) and explore changes in connectivity (MRI at rest) and the biochemical markers (spectroscopy) promoted by the interventions made. • Analyze whether the microstructural integrity (tractography) of regions not damaged by stroke act as surrogate indicators of prediction of response to different treatments, which will allow a better selection of therapeutic strategies in future studies. • Evaluate if the benefits achieved in different domains are maintained in the long term (three months) after the interruption of the treatments.;Primary end point(s): Gravity of aphasia: Aphasia ratio of the Western Aphasia Battery (WAB). Changes in communication: Communicative Ability Log (CAL). Changes in mood (Depression): Stroke Aphasic Depression Questionnaire (SADQ). Changes in quality of life: Stroke Aphasia Quality of Life 39 (SAQoL39).;Timepoint(s) of evaluation of this end point: Week 0 (baseline) , week 8, week 10 and week 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • WAB Subtests including: spontaneous language, listening comprehension, repetition and denomination. • Battery Assessment Aphasic Disorders - BETA (tests: 1, 2, 4, 5, 6, 13, 14, 19, 20, 21, and 26) • Attention: WISC-IV Repetition of digits. • Repeat clichés / novel phrases • New words learning task • Executive function (BADS test). • Function of the right hemisphere (cubes of Corsi, line orientation judgment). • Attention Network Test (ANT) • Catastrophic Reaction Scale • Structural and functional neuroimaging (changes in functional MRI, resting MRI, tensor diffusion NMR - tractography, cortical thickness measurements).;Timepoint(s) of evaluation of this end point: week 0 (baseline), week 8 and week 10 | — |
Countries
Spain
Contacts
Public ContactPlataforma de Estudios Clínicos
FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud
Outcome results
None listed