Status:
UNKNOWN
Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer Disease
Lead Sponsor:
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Conditions:
Alzheimer Disease
Transcranial Magnetic Stimulation
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
Randomized clinical trial, comparative and single blind aims to determine effects on cognition, psychological and behavioral symptoms and functionality of 5 Hz repetitive transcranial magnetic stimula...
Detailed Description
Alzheimer disease (AD) is a neurodegenerative disorder characterized by progressive cognitive decline that affects behavior and daily functionality. Its etiology is unknown and treatment efficacy is p...
Eligibility Criteria
Inclusion
- Patients with file number at National Institute of Psychiatry "Ramón de la Fuente Muñiz".
- Scholarship of at least 5 years or above.
- Dementia diagnosis established by clinical examination made by their responsible physician, according the Diagnose Criteria for Alzheimer Disease for possible, mild or moderate according to DSM-5. Severity will be stratified with Mini-Mental State (MMSE-FOLSTEIN): as a) mild: 21-26 and b) moderated 15-20 points; in addition, with Reisberg Global Deterioration, the states from 2 to 4 that correspond a cognitive deficit mild and moderated.
- In the case of concomitant treatment with memantine or acetylcholinesterase inhibitors, the patient should have taken it for at least 6 months prior to study.
- In the case of other pharmacological treatments for psychiatric conditions, for example, antidepressants, anxiolytic or antipsychotics, the patient should have taken stable doses for at least 2 months.
- Patients with another no-psychiatric comorbidity should be stable (according to diagnostic criteria and supported by laboratory studies or metric assessments).
- Every patient should have a caregiver (for example, spouse, a relative or a professional caregiver) along the study who could stay with the patient at least 10 hours/week.
- Signing of informed consent by patient and caregiver.
- Patients and caregivers who can attend in weekdays, along three weeks assessments and treatment sessions at National Institute of Psychiatry "Ramón de la Fuente Muñiz".
Exclusion
- Patients with severe agitation symptoms or difficulties to cooperate with the study.
- Patients with history of epilepsy.
- Patients with sudden onset of apoplexy, focal neurologic findings as hemiparesis, sensory loss, visual field deficit and lack of coordination in the legs in early stages of disease.
- Convulsion or walking disorder at onset or very early stages of the disease.
- Patients with history of severe psychiatric disorders.
- Patients with alterations in a conventional electroencephalogram (paroxysmal phenomena identified by a specialized clinical neurophysiologist).
- Patients with pacemaker or implanted metallic intracranial objects.
- Elimination criteria:
- Decision of patient or caregiver to left the study.
- Modification in doses or pharmacological treatment prior to start the study.
- Patients with new clinical findings and who require complementary pharmacological treatment.
- Presence of adverse events that could affect health and could limit maintain the patient in treatment.
- Exacerbation of cognitive or behavioral symptoms during the study.
Key Trial Info
Start Date :
March 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03270137
Start Date
March 10 2016
End Date
August 31 2017
Last Update
September 1 2017
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