Effects of a Combined Transcranial Magnetic Stimulation (TMS) and Cognitive Training in Alzheimer Patients
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01504958 |
|
Recruitment Status :
Completed
First Posted : January 6, 2012
Results First Posted : June 5, 2017
Last Update Posted : July 2, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Behavioral: NICE Cognitive Training | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 22 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (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 |
| Study Start Date : | December 2010 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | May 2015 |
| Arm | Intervention/treatment |
|---|---|
|
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:
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:
|
|
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:
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:
|
|
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:
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:
|
- 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).
- 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.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 55 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504958
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Alvaro Pascual-Leone, M.D., Ph.D. | Beth Israel Deaconess Medical Center |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alvaro Pascual-Leone, Professor of Neurology, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT01504958 |
| Other Study ID Numbers: |
2010P000325 |
| First Posted: | January 6, 2012 Key Record Dates |
| Results First Posted: | June 5, 2017 |
| Last Update Posted: | July 2, 2017 |
| Last Verified: | June 2017 |
|
Alzheimer's disease Cognitive Training Transcranial Magnetic Stimulation |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |