Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatments repetitive transcranial magnetic stimulation (rtms), nice cognitive training
Phase phase 2
Sponsor Beth Israel Deaconess Medical Center
Collaborator Neuronix Ltd
Start date December 2010
End date October 2014
Trial size 20 participants
Trial identifier NCT01504958, 2010P-000325

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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).
repetitive transcranial magnetic stimulation (rtms) Transcranial Magnetic Stimulation
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 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 real cognitive training that follows the same procedures as the active group.
(Sham Comparator)
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).
repetitive transcranial magnetic stimulation (rtms) Transcranial Magnetic Stimulation
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 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 real cognitive training that follows the same procedures as the active group.

Primary Outcomes

Measure
Alzheimer's Disease Assessment Scale (ADAS-Cog)
time frame: Pre treatment; post treatment; 1, 2, and 3 months post treatment

Secondary Outcomes

Measure
Weschler Test of Adult Reading (WTAR)
time frame: Pre-treatment, post treatment
Clinical Global Impression Change (CGIC)
time frame: Pre-treatment, post treatment
Modified Rey Auditory Verbal Learning Test (RAVLT)
time frame: Pre-treatment; post treatment; 1, 2, and 3 months post treatment
NACC's UDS Neuropsychological Battery Test
time frame: Pre-treatment, post treatment

Eligibility Criteria

Male or female participants from 55 years up to 90 years old.

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

Additional Information

Official title Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study
Principal investigator Alvaro Pascual-Leone, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.