Effect of Repetitive Transcranial Magnetic Stimulation on Language in Alzheimer's Disease
Condition: Alzheimer's Disease; Aphasia; Dementia
MeSH terms: Alzheimer Disease; Aphasia
Intervention: Repetitive Transcranial Magnetic Coil Stimulation (rTMS)
Intervention description: The first six patients were administered rTMS at 10Hz in 20 trains of 5 seconds with 20 second intervals between trains in each hemisphere. The total number of pulses for each session was set at 1000 pulses. The second six enrolled patients were administered rTMS at 15 Hz in 20 trains of 5 seconds with 25 second intervals between trains in each hemisphere.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Alzheimer; Language; Treatment; TMS; rTMS

Summary:

      The investigators wish to investigate the efficacy of targeted repetitive transcranial
      magnetic stimulation (rTMS) on expressive language in patients with Alzheimer's disease (AD).
      In rTMS, magnetic pulses are used to noninvasively stimulate focal areas of cortex of about a
      square centimeter in area. rTMS has been approved in the United States for the diagnosis of
      peripheral nerve conditions.

      Depending on the frequency of stimulation, rTMS can preferentially stimulate or inhibit
      cortical areas. In stroke rehabilitation, for example, inhibition of the contralateral,
      uninvolved hemisphere by low frequency rTMS has improved movement of the affected limbs
      because of less aberrant inhibition of the affected hemisphere by the healthy hemisphere. The
      effects of rTMS has also been investigated and found to be useful in treating refractory
      depression and depression in Parkinson's disease. In addition, rTMS has improved naming in
      patients with Alzheimer's disease and has improved cognitive abilities and memory in
      non-demented older adults. Two studies found that rTMS improved aphasia in patients with
      stroke. While these studies are small, a review of the literature suggests that there may be
      a beneficial role for rTMS in patients with chronic neurological conditions. In addition,
      rTMS appears to be well tolerated, with transient headaches being the most common side
      effect.

      In this small open label study, the investigators wish to investigate the usefulness of
      bilateral stimulation of the brain region termed the dorsolateral prefrontal cortex (DLPFC)
      in patients with AD who have naming and language deficits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a diagnosis of probable or possible Alzheimer's disease, diagnosed
             using standardized criteria.

          -  If subjects are determined by the PI to lack decisional capacity to consent to the
             study, a legally authorized representative must be available to sign the informed
             consent on behalf of the subject. In this case the assent of each subject will be
             obtained as well. If at any time the subject withdraws his or her assent, the subject
             will be disenrolled from the study.

          -  Subjects will score at or below 30 on the 60 item naming section of the Boston
             Diagnostic Aphasia and/or below 50% on the Controlled Word Association (CFL) Category
             Naming.

        Exclusion Criteria:

          -  Subjects newly diagnosed with AD and not yet receiving usual care are not eligible.

          -  Subjects must not have pacemakers.

          -  They must not have a history of implanted metal objects.

          -  They must not have a history of seizures or epilepsy.

          -  There must not be any recent history of migraines.

          -  There must not be any history of uncontrolled depression.

          -  They must not be on any medications that will significantly lower the seizure
             threshold.

          -  Any other medical condition that is judged by the PI to make rTMS unsafe for the
             subject.