Transcranial Magnetic Stimulation for Alzheimer's Disease Treatment
ConditionAlzheimer Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-75
SponsorUniversitat Oberta de Catalunya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Active Transcranial Magnetic Stimulation
DeviceThe intervention consists of a 2-week treatment during which TMS will be applied for 10 days (every working day). The stimulation protocol will be intermittent TBS (iTBS). 600 pulses in each area will be applied at intervals of 2 seconds of stimulation and 8 seconds of rest; the total number of pulses per session will be 1200. The stimulation duration is 3 minutes and 12 seconds. This protocol allows the induction of long-term potentiation effects, promoting plasticity in the stimulated areas. To perform the stimulation a 70 mm, figure of 8-coil will be used. In order to precisely locate the stimulated areas a stereotactic image guidance will be used during the stimulation (Brainsight™ 2)
Sham Transcranial Magnetic Stimulation
DeviceThe Sham intervention will be carried out using the same stimulation protocol as in the active condition but with the coil rotated 90º to prevent the magnetic field inducing electrical activity in the cortex.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Experimental groupActive comparator 1 intervention
Group B: Sham control groupSham comparator 1 intervention
Group C: Non TMS Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Cognitive improvement
Changes in cognitive functions will be assessed through a Neuropsychological Batery
Time frame
Baseline and 1 month, 3 months and 6 months after the end of the treatmentSecondary outcomes
1
Functional capacity changes_1
Functional capacity will be assessed through the Functional Assessment Questionnaire (FAQ)
Time frame
Baseline and 1 month, 3 months and 6 months after the end of the treatment2
Functional capacity changes_2
Functional capacity will be assessed through the UCSD Performance-Based Skills Assessment (UPSA)
Time frame
Baseline and 1 month, 3 months and 6 months after the end of the treatment3
Mood changes
Mood changes will be assessed through the Hospital Anxiety and Depression Scale (HAD)
Time frame
Baseline and 1 month, 3 months and 6 months after the end of the treatment4
Changes in brain connectivity
Brain connectivity will be assessed through the registry of brain activity in the resting state Magnetic Resonance Imaging.
Time frame
3 days after the end of the treatmentLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitat Oberta de Catalunya
Lead sponsor
Consorci Sanitari de Terrassa
Collaborator
Source ClinicalTrials.gov
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