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

Alzheimer's Disease Clinical Trial

Official title:

Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01504958
• Other study ID #: 2010P-000325
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 29, 2011
• Last updated: May 28, 2014
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Device:
• 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.

Behavioral:
• 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 real cognitive training that follows the same procedures as the active group.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Neuronix Ltd

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale (ADAS-Cog)	Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention.	Pre treatment; post treatment; 1, 2, and 3 months post treatment	No
Secondary	Weschler Test of Adult Reading (WTAR)	Brief test to estimate level of intelligence	Pre-treatment, post treatment	No
Secondary	Clinical Global Impression Change (CGIC)	A three-item scale used to assess treatment response in psychiatric patients. They are severity of illness, global improvement, and efficacy index.	Pre-treatment, post treatment	No
Secondary	Modified Rey Auditory Verbal Learning Test (RAVLT)	Assess immediate and delayed memory function.	Pre-treatment; post treatment; 1, 2, and 3 months post treatment	No
Secondary	NACC's UDS Neuropsychological Battery Test	Consists of: Logical memory (immediate and delayed); Digit span forward; Digit span backward; Category fluency (animals and vegetables); WAIS-R Digit symbol; Boston naming test	Pre-treatment, post treatment	No

External Links

•   Related Information regarding the TMS lab at Beth Israel Deaconess Medical Center
•   Related Information to the Alzheimer's Trial; sponsors website.