Clinical trial NCT01504958: Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients
Official title: Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Cognitive Training
Transcranial Magnetic Stimulation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Neuronix Ltd
First posted: 2012-01-06
Enrollment: 22
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
timeFrame: Pre treatment; 1 month post treatment
Secondary outcomes:
measure: Clinical Global Impression of Change (CGIC)
timeFrame: Pre-treatment, 1 month post treatment
measure: Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
timeFrame: Pre-treatment, 1 month Post-treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Alvaro Pascual-Leone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bentwich J, Dobronevsky E, Aichenbaum S, Shorer R, Peretz R, Khaigrekht M, Marton RG, Rabey JM. Beneficial effect of repetitive transcranial magnetic stimulation combined with cognitive training for the treatment of Alzheimer's disease: a proof of concept study. J Neural Transm (Vienna). 2011 Mar;118(3):463-71. doi: 10.1007/s00702-010-0578-1. Epub 2011 Jan 19.
citation: Brem AK, Di Iorio R, Fried PJ, Oliveira-Maia AJ, Marra C, Profice P, Quaranta D, Schilberg L, Atkinson NJ, Seligson EE, Rossini PM, Pascual-Leone A. Corticomotor Plasticity Predicts Clinical Efficacy of Combined Neuromodulation and Cognitive Training in Alzheimer's Disease. Front Aging Neurosci. 2020 Jul 8;12:200. doi: 10.3389/fnagi.2020.00200. eCollection 2020.