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

Beth Israel Lahey Health

Status: Completed

Conditions: Alzheimer's Disease

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01504958

2010P000325

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 3 patient groups

Active rTMS with real cognitive training

Active Comparator group

Description:

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.

Treatment:

Behavioral: NICE Cognitive Training

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS with real cognitive training

Sham Comparator group

Description:

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.

Treatment:

Behavioral: NICE Cognitive Training

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS with sham cognitive training

Sham Comparator group

Description:

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.

Treatment:

Behavioral: NICE Cognitive Training

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)