View Clinical Trial (Medical Research Study)
Open-label, Exploratory Study of the Efficacy of Repetitive Transcranial Magnetic Stimulation on Naming and Verbal Fluency in Patients With Alzheimer's Disease
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10021 |
| Conditions: |
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Alzheimer's Disease - Aphasia - Language Difficulties - Dementia |
| Purpose: |
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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.
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| Study Summary: |
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Subjects for this study will be recruited from Dr. Devi's clinical practice. Eligible
subjects must have a diagnosis of possible or probable Alzheimer's disease using
NINCDS-ADRDA criteria. If it is determined by the principal investigator that the subject
lacks decisional capacity to consent or refuse to participate in the current study, a
legally authorized representative must be available to sign the informed consent. The assent
of the incapable subject will be obtained prior to enrolling the subject in the study.
Once informed consent and assent are obtained, the subject will have a functional magnetic
resonance imaging (fMRI) scan of their brain anytime during the 2 weeks prior to the first
study visit. At Visit 1, subjects will undergo a baseline battery of cognitive tests lasting
approximately 30 minutes. Subsequently, the subject will undergo rTMS.
During the visit, Dr. Devi will locate the area of the brain to be stimulated and mark that
area of the scalp with an indelible skin marker that will wash out over time. In addition,
the subjects will be provided with ear plugs to use during stimulation. This process of
locating the area to be stimulated will take about an hour and will occur once. Then rTMS
will be started and this procedure will take approximately 20-30 minutes (please see the
full protocol for a complete description of this process).
Each rTMS stimulation session will last for about 30 minutes, 2 consecutive days a week for
2 weeks. Both immediately prior to the onset of the first rTMS session, and just after the
end of the fourth and final rTMS session, subjects will be tested on their cognitive and
language skills. These two testing sessions will last 30 minutes each. Subjects will have
another fMRI scan anytime during the 2 days after the fourth and final rTMS stimulation
session.
Subjects will continue to receive usual care throughout the study period. Any changes to
usual treatment will be noted in the study file.
All subjects will be seen again 4 weeks after the final study treatment session and will
once again undergo the brief cognitive battery and fMRI scan.
The investigators expect to recruit two subjects at a time for the study and each subject
will be enrolled for 5 weeks from the baseline visit.
The investigators wish to recruit 10 subjects in total for the study and expect to have
completed the study in approximately 1 year.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00814697 |
| Primary Contact: |
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Principal Investigator
Gayatri Devi, MD
The New York Memory Services
Kyra Doumlele, BA
Phone: 2125176881
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| Backup Contact: |
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Dani Levine, BS
Phone: 2125176881
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| Location Contact: |
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New York, New York 10021
United States
Elizabeth Shin, BA
Phone: 212-517-6881
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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