Phase 2
N=12
Effect of Repetitive Transcranial Magnetic Stimulation on Language in Alzheimer's Disease
Alzheimer's Disease · Aphasia · Dementia
Bottom Line
View on ClinicalTrials.gov: NCT00814697 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Cognitive Assessment Task Scores Before, During and After rTMS. — 26.9; 13.3; 17.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Repetitive Transcranial Magnetic Coil Stimulation (rTMS) (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- The New York Memory Services
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Assessment Task Scores Before, During and After rTMS. |
26.9; 13.3; 17.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00814697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.