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
1 other identifier
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
June 5, 2017
CompletedJuly 2, 2017
June 1, 2017
4.4 years
September 29, 2011
January 13, 2017
June 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale - Cognitive Subscale (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. 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).
Pre treatment; 1 month post treatment
Secondary Outcomes (2)
Clinical Global Impression of Change (CGIC)
Pre-treatment, 1 month post treatment
Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
Pre-treatment, 1 month Post-treatment
Study Arms (3)
Active rTMS with real cognitive training
ACTIVE COMPARATORHigh 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.
Sham rTMS with real cognitive training
SHAM COMPARATORHigh 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.
Sham rTMS with sham cognitive training
SHAM COMPARATORHigh 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- Neuronix Ltdcollaborator
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (2)
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.
PMID: 21246222BACKGROUNDBrem AK, Di Iorio R, Fried PJ, Oliveira-Maia AJ, Marra C, Profice P, Quaranta D, Schilberg L, Atkinson NJ, Seligson EE, Rossini PM, Pascual-Leone A. Corticomotor Plasticity Predicts Clinical Efficacy of Combined Neuromodulation and Cognitive Training in Alzheimer's Disease. Front Aging Neurosci. 2020 Jul 8;12:200. doi: 10.3389/fnagi.2020.00200. eCollection 2020.
PMID: 32733232DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alvaro Pascual-Leone, M.D., Ph.D.
- Organization
- Beth Israel Deaconess Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Alvaro Pascual-Leone, M.D., Ph.D.
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
September 29, 2011
First Posted
January 6, 2012
Study Start
December 1, 2010
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
July 2, 2017
Results First Posted
June 5, 2017
Record last verified: 2017-06