Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients

Not Applicable

Completed

Conditions: Alzheimer's Disease

Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Behavioral: NICE Cognitive Training

Registration Number: NCT01504958

Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS with real cognitive training	Repetitive Transcranial Magnetic Stimulation (rTMS)	High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent active cognitive training.
Sham rTMS with sham cognitive training	NICE Cognitive Training	High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent sham cognitive training.
Sham rTMS with real cognitive training	Repetitive Transcranial Magnetic Stimulation (rTMS)	High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent active cognitive training.
Sham rTMS with real cognitive training	NICE Cognitive Training	High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent active cognitive training.
Sham rTMS with sham cognitive training	Repetitive Transcranial Magnetic Stimulation (rTMS)	High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent sham cognitive training.
Active rTMS with real cognitive training	NICE Cognitive Training	High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area) paired with concurrent active cognitive training.

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)	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 Outcome Measures

Name	Time	Method
Clinical Global Impression of Change (CGIC)	Pre-treatment, 1 month post treatment	The CGI is a three-item scale used to assess treatment response in psychiatric patients. The CGI-C subset measures the global improvement or change from baseline. Scores range from 0 to 7, with 0 indicating marked improvement and 7 indicating marked worsening. The scores below represent the percent change of the scores from baseline.
Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)	Pre-treatment, 1 month Post-treatment	23 item scale to assess activities of daily living. Scores range from 0 to 78 with a higher score indicating less functional impairment. The scores reported below are the means of the actual scores from the assessments representing the percent change from baseline.