Study of the Effect of Repetitive Transcranial Magnetic Stimulation on Language in Patients With Alzheimer's Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease Aphasia Language Difficulties Dementia |
Device: Repetitive Transcranial Magnetic Coil Stimulation (rTMS) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-label, Exploratory Study of the Efficacy of Repetitive Transcranial Magnetic Stimulation on Naming and Verbal Fluency in Patients With Alzheimer's Disease |
- Change in language in patients with Alzheimer's Disease [ Time Frame: 2 months ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: rTMS
rTMS treatment in Alzheimer's disease
|
Device: Repetitive Transcranial Magnetic Coil Stimulation (rTMS)
Using rTMS to treat language deficits in Alzheimer's patients
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, New York | |
| The NY Memory Services | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Gayatri Devi, MD | The New York Memory Services |
More Information
No publications provided
| Responsible Party: | Gayatri Devi, MD, Clinical Associate Professor of Neurology & Psychiatry, The New York Memory Services |
| ClinicalTrials.gov Identifier: | NCT00814697 History of Changes |
| Other Study ID Numbers: | 91913-5 |
| Study First Received: | December 24, 2008 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The New York Memory Services:
|
Alzheimer Language Treatment TMS rTMS |
Additional relevant MeSH terms:
|
Alzheimer Disease Aphasia Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013