Transcranial Magnetic Stimulation for Alzheimer's Disease Treatment (TMSAD)
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|ClinicalTrials.gov Identifier: NCT03121066|
Recruitment Status : Not yet recruiting
First Posted : April 19, 2017
Last Update Posted : July 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Device: Active Transcranial Magnetic Stimulation Device: Sham Transcranial Magnetic Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The design of the study is a randomized, double blind, parallel clinical trial.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Intervention Based on Transcranial Magnetic Stimulation for Alzheimer's Disease Patients: Randomized Clinical Trial|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
Active Comparator: Experimental group
Transcranial Magnetic Stimulation + Conventional intervention
Device: Active Transcranial Magnetic Stimulation
The 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)
Other Name: Magstim Super Rapid 2
Sham Comparator: Sham control group
Sham Transcranial Magnetic Stimulation + Conventional intervention
Device: Sham Transcranial Magnetic Stimulation
The 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.
Other Name: Magstim Super Rapid 2
No Intervention: Non TMS Control group
Conventional intervention alone
- 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
- Functional capacity changes [ Time Frame: Baseline and 1 month, 3 months and 6 months after the end of the treatment ]Functional capacity will be assessed through the Functional Assessment Questionnaire (FAQ)
- Functional capacity changes [ Time Frame: Baseline and 1 month, 3 months and 6 months after the end of the treatment ]Functional capacity will be assessed through the UCSD Performance-Based Skills Assessment (UPSA)
- Mood changes [ Time Frame: Baseline and 1 month, 3 months and 6 months after the end of the treatment ]Mood changes will be assessed through the Hospital Anxiety and Depression Scale (HAD)
- Changes in brain connectivity [ Time Frame: 3 days after the end of the treatment ]Brain connectivity will be assessed through the registry of brain activity in the resting state Magnetic Resonance Imaging.