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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Neuronix Ltd
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01504958
First received: September 29, 2011
Last updated: May 28, 2014
Last verified: May 2014

September 29, 2011
May 28, 2014
December 2010
October 2014   (final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale (ADAS-Cog) [ Time Frame: Pre treatment; post treatment; 1, 2, and 3 months post treatment ] [ Designated as safety issue: No ]
Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention.
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. ] [ Designated as safety issue: No ]
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
  • Weschler Test of Adult Reading (WTAR) [ Time Frame: Pre-treatment, post treatment ] [ Designated as safety issue: No ]
    Brief test to estimate level of intelligence
  • Clinical Global Impression Change (CGIC) [ Time Frame: Pre-treatment, post treatment ] [ Designated as safety issue: No ]
    A three-item scale used to assess treatment response in psychiatric patients. They are severity of illness, global improvement, and efficacy index.
  • Modified Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Pre-treatment; post treatment; 1, 2, and 3 months post treatment ] [ Designated as safety issue: No ]
    Assess immediate and delayed memory function.
  • NACC's UDS Neuropsychological Battery Test [ Time Frame: Pre-treatment, post treatment ] [ Designated as safety issue: No ]

    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
Not Provided
Not Provided
Not Provided
 
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
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 real cognitive training that follows the same procedures as the active group.

    Other Names:
    • Cognitive Training
    • Mental exercises
  • Active Comparator: Active rTMS
    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).
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    • Behavioral: NICE Cognitive Training
  • Sham Comparator: Sham rTMS
    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).
    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. 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.
 
Active, not recruiting
20
December 2014
October 2014   (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
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01504958
2010P-000325
No
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
May 2014

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