Intervention Based on Transcranial Magnetic Stimulation for Alzheimer's Disease Patients: Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- Universitat Oberta de Catalunya
- Enrollment
- 45
- Primary Endpoint
- Change in Cognitive improvement
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Background: Alzheimer's disease is a major health problem in our society. To date, pharmacological treatments to reduce Alzheimer's disease symptoms have obtained poor results and there is a growing interest in finding non-pharmacological treatments for this impactful disease. Transcranial Magnetic Stimulation is a non-invasive tool which can induce changes in brain activity and long term modifications of impaired neural networks, and therefore holds promise as a clinical intervention.
Our overall goal is to study the benefit of targeting Transcranial Magnetic Stimulation based on the individual's unique functional connectivity (personalized targeting) instead of current non-individualized approaches. Specifically, the intermittent Theta Burst protocol will be used and changes in cognitive, functional, and emotional deficits in these patients will be evaluated. Functional brain connectivity changes induced by the TMS treatment will be also assessed.
Methods: A double blind randomized controlled trial will be conducted to assess the effects of TMS treatment immediately, one month, three months and six months after the end of the treatment in comparison to the baseline measurements. Forty-five patients with a diagnosis of Alzheimer's disease, will be randomly allocated (1:1:1) into experimental (active Transcranial Magnetic Stimulation), sham control group, or conventional intervention control group. Neuropsychological, functional, and emotional assessment will be conducted, as well as functional connectivity measures, in order to assess the effectiveness of the treatment.
Discussion: The investigators expect to demonstrate that personalized Transcranial Magnetic Stimulation intervention has measurable positive impact in cognitive and emotional functioning, functionality, and brain connectivity, thus representing a potential treatment for Alzheimer's disease.
Investigators
Elena Munoz Marron
Principal Investigator
Universitat Oberta de Catalunya
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Alzheimer's disease according to the diagnostic criteria of the National Institute on Ageing and the Alzheimer's Association
- •Ages between 60 and 75 years
- •Mini Mental State Examination score between 20 and 26
- •Global Deterioration Scale score of 3 or 4
- •Functional independence for basic daily life activities (part C of the Blessed Scale equal or 0)
- •Rosen Ischemia Scale less or equal to 4
- •Able to read and write
- •Stable medical and pharmacological state during the 3 consecutive months immediately before the start of the study
- •Computed Tomography Scan and Magnetic Resonance Imaging in the last 12 months previous to the selection, compatible with the diagnosis of probable Alzheimer's disease in the subjects diagnosed
- •Absence of clinically significant anomalies in the medical history or clinical laboratory results during the selection
Exclusion Criteria
- •Knowledge of Spanish or Catalan after the age of 15
- •Less than 4 years of schooling
- •Intellectual deficiency (Premorbid Intelligence Quotient, vocabulary, less than 85)
- •Not controlled medical conditions or severe mental disorders that may affect the Central Nervous System, including signs of increased intracranial pressure or intracranial lesions
- •Presenting one or more vascular risks
- •Medical conditions not controlled that may cause medical emergencies in case the produce convulsions (expel: cardiac malformations, cardiac arrhythmias, asthma, etc.)
- •Medical history of convulsions, previous diagnosis of epilepsy, previous registry of abnormal electroencephalogram or family history of epilepsy
- •Severe hearing problems or ringing in the ears (tinnitus)
- •Severe loss of visual acuity
- •Moderate or severe depression according to a score \>11 (moderate depression) or 19 (severe depression) in the Geriatric Depression Scale
Outcomes
Primary Outcomes
Change in Cognitive improvement
Time Frame: Baseline and 1 month, 3 months and 6 months after the end of the treatment
Changes in cognitive functions will be assessed through a Neuropsychological Batery
Secondary Outcomes
- Changes in brain connectivity(3 days after the end of the treatment)
- Mood changes(Baseline and 1 month, 3 months and 6 months after the end of the treatment)
- Functional capacity changes_1(Baseline and 1 month, 3 months and 6 months after the end of the treatment)
- Functional capacity changes_2(Baseline and 1 month, 3 months and 6 months after the end of the treatment)