Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Alvaro Pascual-Leone
Professor of Neurology
Beth Israel Deaconess Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time Frame: Pre treatment; 1 month post treatment
Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention. The total scoring range is 0-70, with 0 representing the least impairment and 70 the most severe impairment. The results posted below represent a change in score from baseline. A positive change represents an improvement on the ADAS-Cog (change = 1 month score - baseline score).
Secondary Outcomes
- Clinical Global Impression of Change (CGIC)(Pre-treatment, 1 month post treatment)
- Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)(Pre-treatment, 1 month Post-treatment)