Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02215 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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This study looks at the potential benefits of combining cognitive training (mental
exercises) together with transcranial magnetic stimulation (also known as TMS) to see if
this can make a difference in the condition of people with Alzheimer's disease by improving
their disease and the cognitive decline that goes along with it.
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| Study Summary: |
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This study takes place in Boston, Massachusetts and Beth Israel Deaconess Medical Center.
The treatment portion of the study requires patients to visit the BIDMC daily, Monday
through Friday, for 6 weeks. All participants will receive real cognitive training, but half
of our participants will receive active TMS treatment and half will receive a placebo TMS
treatment. However, those receiving the placebo treatment will be offered the real treatment
upon the completion of the study. This study goes up to approximately 4.5 months.
TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve
any needles or any form of surgery. It acts by delivering a magnetic stimulation to a
particular region of your brain and that, coupled with the cognitive training, is what is
being looked at in this study. The investigators are examining if this combination of TMS
and cognitive training will improve your memory function and other mental functions such as
language, orientation, and thinking or judgment.
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| Criteria: |
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Inclusion Criteria:
- Male or female age 55-90
- Diagnosed with mild to moderate AD according to DSM-IV criteria
- Diagnosis of dementia of the Alzheimer's type according to the criteria established
by the NINCDS-ADRDA
- Normal or corrected normal ability to see and hear
- Primary language is English
Exclusion Criteria:
- IQ below 85
- Any major structural abnormalities on MRI (eg. Infarction, intracerebral
malformation)
- Any symptoms of disease or abnormalities sufficient to cause memory impairment other
than AD (eg. Normal pressure hydrocephalus, progressive supranuclear palsy)
- Any functional psychiatric disorder (eg. Schizophrenia)
- Chronic uncontrolled medical conditions that may cause a medical emergency in case of
a provoked seizure (eg. Cardiac malformation)
- History of seizures, diagnosis of epilepsy
- Metal implants excluding dental fillings or any of the following medical devices:
pacemaker, implanted medication pump, vagal nerve stimulator, deep brain stimulator,
TENS unit (unless removed completely for this study), cerebral spinal fluid shunt
- Recent withdrawal from the following drugs: alcohol, barbiturates, benzodiazepines,
meprobamate, chloral hydrate
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| NCT ID: |
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NCT01504958 |
| Primary Contact: |
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Principal Investigator
Alvaro Pascual-Leone, M.D., Ph.D.
Beth Israel Deaconess Medical Center
Natasha J Atkinson, B.A.
Phone: 617-667-0258
Email: natkinso@bidmc.harvard.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02215
United States
Natasha J Atkinson, B.A.
Phone: 617-667-0258
Email: natkinso@bidmc.harvard.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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