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

This study has been completed.
Sponsor:
Collaborator:
Neuronix Ltd
Information provided by (Responsible Party):
Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01504958
First received: September 29, 2011
Last updated: June 5, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Alzheimer's Disease Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Behavioral: NICE Cognitive Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: December 2010
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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
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.
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

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

Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504958

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Neuronix Ltd
Investigators
Principal Investigator: Alvaro Pascual-Leone, M.D., Ph.D. Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Alvaro Pascual-Leone, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01504958     History of Changes
Other Study ID Numbers: 2010P000325
Study First Received: September 29, 2011
Results First Received: January 13, 2017
Last Updated: June 5, 2017

Keywords provided by Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center:
Alzheimer's disease
Cognitive Training
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 25, 2017