Evaluación clínica de los efectos de un agonista colinérgico (Donezepilo) en la rehabilitación de la memoria en pacientes con traumatismo craneoencefálico

Conditions: Traumatic Brain Injury (TBI)

Registration Number: EUCTR2005-001464-30-ES

Lead Sponsor: Institut Universitari de Neurorehabiltació Guttmann

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Mild or severe TBI patients with Glasgow Coma Scale = 8
Awareness of a deficit in memory
Memory affection detected by their families (Cuestionario de Olvidos Cotidianos-COC)
Patients with cognitive functions preserved, able to focus and keep attention, to understand orders and give verbal and motor responses depending on the task to do.

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Premorbid intellectual alteration
Psychiatric disorders
TBIs recurrent
Stroke or additional neurological pathology
Aphasia and/or anomia
Sensory disorders (Visual or Auditory problems)
Aricept contraindications
Neuropsycologic affectation (Attention Span less than 5 points)
Posttraumatic amnesia
Patient in legal procedures (indemnity stage)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): ;Secondary Objective: This is a double blind placebo controlled clinical trial associated to a systemized neuropsycological intervention.<br><br>The study seeks to compare the efficacy of Donepezilo versus placebo in the rehabilitation of memory on people who are receiving a systemized neuropsycological treatment.<br>Other purpose is to compare the efficacy of Donezepilo in patients with a neuropsycological intervention versus those who are not receiving such intervention.<br>;Main Objective: The objective of this trial is to assess the efficacy of Donepezilo (Aricept®) in the Neuropsycological Rehabilitation on TBI patients.

Secondary Outcome Measures