CompletedPhase 2

Cognitive Rehabilitation and Galantamine for Post Stroke Cognitive Impairment

France47 participantsStarted 2011-06-29

Plain-language summary

The investigators would like to conduct a double blind placebo-controlled prospective study to show the impact of a treatment combining a specific cognitive rehabilitation program and acetylcholinesterase inhibitors on executive function of young patients 3 months after a first symptomatic stroke. The secondary objectives will be to assess cognitive changes performance (executive but also non trained functions such as memory) before and after treatments and treatment effect on activity of daily living and on quality of life. The main objective of this study is to show the impact of this combined treatment on brain activation maps in VCI-ND patients in the post-acute phase (3 months) after a stroke. Treatment effect will be assessed by functional MRI (fMRI) while patients will be performing a specific executive task. The investigators hypothesize that the specific rehabilitation associated with acetylcholinestrase inhibitors treatment will focalize cerebral activation observed in fMRI, improve executive functions specifically, improve non trained cognitive functions (generalization effect).

Who can participate

Age range35 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written consent form signed by the patient, * Patient must be affiliated with a social security system, * Age: 35-70, * First symptomatic stroke, * Brain ischemic lesion on MRI DWI consistent with a recent ischemic stroke, * Absence of cognitive decline before the stroke, * Detailed cognitive complaint of patient or the environment, * Patients with a cognitive impairment (VCI-ND criteria: impairment in at least one cognitive domain with a score below 2 standard deviation according to clinical norms in at least two cognitive functions exploring this domain. VCI-ND was diagnosed in the absence of dementia according to the DSM IV, * Absence of hospitalization for cardiovascular disease from the acute phase of the qualifying event, * NIHSS \< 6, * mRs \< 4, * Absence of aphasia, apraxia and neglect severe, * Patients not previously treated with cholinesterase inhibitors or memantine centrally acting regardless of the duration of treatment and date of prescription, * Visual skills, auditory and oral or written expression sufficient to achieve adequate neuropsychological tests, * Women of childbearing potential must be using contraception and a pregnancy test will be conducted at the screening visit. Exclusion Criteria: * Subjects with contraindication to MRI (a pacemaker or a defibrillator, an implanted material activated by an electrical, magnetic or mechanical carriers of hemostatic clips of intracerebral aneurysms or carotid arteries, bearing orthopedic…

What they're measuring

fMRI

Timeframe: week 20

Trial details

NCT IDNCT01508494

SponsorInstitut National de la Santé Et de la Recherche Médicale, France

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2016-06