Transcranial Magnetic Stimulation for Alzheimer's Disease Treatment

Sponsor
Universitat Oberta de Catalunya
Study ID
NCT03121066
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Transcranial Magnetic Stimulation — DEVICE
    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)
  • Sham Transcranial Magnetic Stimulation — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Apr 19, 2017
Start date
Nov 30, 2027
Status verified
Jul 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Experimental group
    Transcranial Magnetic Stimulation + Conventional intervention
  • Sham Comparator: Sham control group
    Sham Transcranial Magnetic Stimulation + Conventional intervention
  • No Intervention: Non TMS Control group
    Conventional intervention alone

Primary Outcome Measure

Change in Cognitive improvement [ Time Frame: Baseline and 1 month, 3 months and 6 months after the end of the treatment ]

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