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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504958
First Posted: January 6, 2012
Last Update Posted: July 2, 2017
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.
Collaborator:
Neuronix Ltd
Information provided by (Responsible Party):
Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center
Results First Submitted: January 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Behavioral: NICE Cognitive Training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).

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.

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.

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).

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.

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.

Sham rTMS With Sham Cognitive Training

High frequency sham 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).

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.

Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group


Participant Flow:   Overall Study
    Active rTMS With Real Cognitive Training   Sham rTMS With Real Cognitive Training   Sham rTMS With Sham Cognitive Training
STARTED   10 [1]   6 [1]   6 [1] 
COMPLETED   10 [2]   6 [2]   6 [2] 
NOT COMPLETED   0   0   0 
[1] Baseline clinical, cognitive, and behavioral assessments: TMS-EMG measures, MRI scan, randomization.
[2] 1 Month Post-Treatment Follow Up



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Total number analyzed: 21 (1 enrolled was excluded from analysis) Real/Real: 10 Real/Sham: 5 Sham/Sham: 6

Reporting Groups
  Description
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).

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.

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.

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).

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.

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.

Sham rTMS With Sham Cognitive Training

High frequency sham 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).

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.

Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group

Total Total of all reporting groups

Baseline Measures
   Active rTMS With Real Cognitive Training   Sham rTMS With Real Cognitive Training   Sham rTMS With Sham Cognitive Training   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   5   6   21 
Age 
[Units: Years]
Mean (Full Range)
 69.1 
 (52 to 76) 
 68.6 
 (54 to 86) 
 70 
 (54 to 86) 
 69.24 
 (52 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      7  70.0%      3  60.0%      2  33.3%      12  57.1% 
Male      3  30.0%      2  40.0%      4  66.7%      9  42.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)   [ Time Frame: Pre treatment; 1 month post treatment ]

2.  Secondary:   Clinical Global Impression of Change (CGIC)   [ Time Frame: Pre-treatment, 1 month post treatment ]

3.  Secondary:   Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)   [ Time Frame: Pre-treatment, 1 month Post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alvaro Pascual-Leone, M.D., Ph.D.
Organization: Beth Israel Deaconess Medical Center
phone: 617-667-0203
e-mail: apleone@bidmc.harvard.edu


Publications:

Responsible Party: Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01504958     History of Changes
Other Study ID Numbers: 2010P000325
First Submitted: September 29, 2011
First Posted: January 6, 2012
Results First Submitted: January 13, 2017
Results First Posted: June 5, 2017
Last Update Posted: July 2, 2017