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Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01551979
First Posted: March 13, 2012
Last Update Posted: June 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:
Sidney R. Baer, Jr. Foundation
Information provided by (Responsible Party):
Mark Halko, Beth Israel Deaconess Medical Center
Results First Submitted: March 15, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Device: Repetitive Transcranial Magnetic Stimulation

  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
22 patients gave informed consent for the study during the initial screening visit. After patients were found ineligible to participate following review of medical records, withdrew consent, or were lost to follow-up, only 17 remained for the randomization phase and started the study.

Reporting Groups
  Description
Active rTMS

High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.

Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.

Sham participants will undergo the same procedures as those in the active rTMS group.

Sham rTMS

Sham rTMS to the vermis (lobule VII) of the cerebellum.

Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.

Sham participants will undergo the same procedures as those in the active rTMS group.


Participant Flow:   Overall Study
    Active rTMS   Sham rTMS
STARTED   9   8 
Last Day of Treatment (After 5 Days of t   9   8 
1 Week Post Treatment   9   7 
COMPLETED   7   6 
NOT COMPLETED   2   2 



  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.
No text entered.

Reporting Groups
  Description
Active rTMS

High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.

Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.

Sham participants will undergo the same procedures as those in the active rTMS group.

Sham rTMS

Sham rTMS to the vermis (lobule VII) of the cerebellum.

Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.

Sham participants will undergo the same procedures as those in the active rTMS group.

Total Total of all reporting groups

Baseline Measures
   Active rTMS   Sham rTMS   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   8   17 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      9 100.0%      8 100.0%      17 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  11.1%      3  37.5%      4  23.5% 
Male      8  88.9%      5  62.5%      13  76.5% 
Region of Enrollment 
[Units: Participants]
     
United States   9   8   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subcale   [ Time Frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]

2.  Primary:   Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale   [ Time Frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]

3.  Primary:   Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subcale   [ Time Frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]

4.  Primary:   Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness   [ Time Frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]

5.  Primary:   Clinical Global Impression (CGI) Global Improvement   [ Time Frame: Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment ]

6.  Secondary:   Change From Baseline on the Calgary Depression Scale for Schizophrenia   [ Time Frame: Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks 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: Mark Halko
Organization: Beth Israel Deaconess Medical Center
phone: 6176670367
e-mail: mhalko@bidmc.harvard.edu


Publications:


Responsible Party: Mark Halko, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01551979     History of Changes
Other Study ID Numbers: 2011P000373
First Submitted: March 1, 2012
First Posted: March 13, 2012
Results First Submitted: March 15, 2017
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017