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

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ClinicalTrials.gov Identifier: NCT01504958
Recruitment Status : Completed
First Posted : January 6, 2012
Results First Posted : June 5, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

September 29, 2011
January 6, 2012
January 13, 2017
June 5, 2017
July 2, 2017
December 2010
May 2015   (Final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: Pre treatment; 1 month post treatment ]
Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention. The total scoring range is 0-70, with 0 representing the least impairment and 70 the most severe impairment. The results posted below represent a change in score from baseline. A positive change represents an improvement on the ADAS-Cog (change = 1 month score - baseline score).
Effects of Transcranial Magnetic Stimulation and Cognitive Training in the clinical outcome of Alzheimer's disease. [ Time Frame: Change from baseline in Neuropsychological Assessments at 1 week after the 6 week treatment period. ]
Neuropsychological evaluations using the ADAS-Cog, W-TAR, RAVL-T and NACC Neuropsychological Battery Tests will be used to assess cognitive function before and after the treatment trial period. In addition, continuous and intermittent Thetaburst Stimulation (cTBS and iTBS) applied with TMS will be used before and after the 6 week rTMS period to assess cortical reactivity and plasticity in the motor cortex (M1), dorsolateral prefrontal cortex (DLPFC) and ipsilateral parietal lobule (IPL). A 3 month follow-up period will help to determine the lasting effects of the 6 week treatment plan.
Complete list of historical versions of study NCT01504958 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression of Change (CGIC) [ Time Frame: Pre-treatment, 1 month post treatment ]
    The CGI is a three-item scale used to assess treatment response in psychiatric patients. The CGI-C subset measures the global improvement or change from baseline. Scores range from 0 to 7, with 0 indicating marked improvement and 7 indicating marked worsening. The scores below represent the percent change of the scores from baseline.
  • Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Pre-treatment, 1 month Post-treatment ]
    23 item scale to assess activities of daily living. Scores range from 0 to 78 with a higher score indicating less functional impairment. The scores reported below are the means of the actual scores from the assessments representing the percent change from baseline.
Not Provided
Not Provided
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Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients
Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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.

    Other Names:
    • Transcranial Magnetic Stimulation
    • Noninvasive Brain Stimulation
  • 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 sham cognitive training that follows the same procedures as the active group.

    Other Names:
    • Cognitive Training
    • Mental exercises
  • Active Comparator: 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.
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    • Behavioral: NICE Cognitive Training
  • Sham Comparator: 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.
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    • Behavioral: NICE Cognitive Training
  • Sham Comparator: 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.
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    • Behavioral: NICE Cognitive Training
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
May 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01504958
2010P000325
No
Not Provided
Not Provided
Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Neuronix Ltd
Principal Investigator: Alvaro Pascual-Leone, M.D., Ph.D. Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP