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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active rTMS with real 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.

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).

Sham participants will receive the same study procedures as patients receiving active rTMS.

NICE Cognitive Training

Intervention Type BEHAVIORAL

12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).

A particular cognitive exercise will start 200msec after the termination of each TMS train.

Sham participants receive sham cognitive training that follows the same procedures as the active group.

Sham rTMS with real 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.

Group Type SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).

Sham participants will receive the same study procedures as patients receiving active rTMS.

NICE Cognitive Training

Intervention Type BEHAVIORAL

12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).

A particular cognitive exercise will start 200msec after the termination of each TMS train.

Sham participants receive sham cognitive training that follows the same procedures as the active group.

Sham rTMS with sham 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.

Group Type SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).

Sham participants will receive the same study procedures as patients receiving active rTMS.

NICE Cognitive Training

Intervention Type BEHAVIORAL

12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).

A particular cognitive exercise will start 200msec after the termination of each TMS train.

Sham participants receive sham cognitive training that follows the same procedures as the active group.

Interventions

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Repetitive Transcranial Magnetic Stimulation (rTMS)

Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).

Sham participants will receive the same study procedures as patients receiving active rTMS.

Intervention Type DEVICE

NICE Cognitive Training

12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).

A particular cognitive exercise will start 200msec after the termination of each TMS train.

Sham participants receive sham cognitive training that follows the same procedures as the active group.

Intervention Type BEHAVIORAL

Other Intervention Names

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Transcranial Magnetic Stimulation Noninvasive Brain Stimulation Cognitive Training Mental exercises

Eligibility 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

Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No