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Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Bipolar Depression

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ClinicalTrials.gov Identifier: NCT00186485
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : June 8, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hugh Brent Solvason, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Intervention: Device: MagStim

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Right Sided Low Frequency Unilateral TMS

1Hz unilateral TMS delivered to the right DLPFC using the MagStim device

MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain


Participant Flow:   Overall Study
    Right Sided Low Frequency Unilateral TMS
STARTED   28 
COMPLETED   25 
NOT COMPLETED   3 
Lost to Follow-up                3 



  Baseline Characteristics

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
Right Sided Low Frequency Unilateral TMS

Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device

MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain


Baseline Measures
   Right Sided Low Frequency Unilateral TMS 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed   28 
<=18 years      0   0.0% 
Between 18 and 65 years      28 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   28 
   34.9  (9.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   28 
Female      18  64.3% 
Male      10  35.7% 
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed   28 
United States   28 
Number of Subjects with Bipolar Subtype Diagnosis at Baseline [1] 
[Units: Participants]
Count of Participants
 
Bipolar Type I   
Participants Analyzed   28 
Bipolar Type I   16 
Bipolar Type II   
Participants Analyzed   28 
Bipolar Type II   11 
Bipolar NOS   
Participants Analyzed   28 
Bipolar NOS   1 
[1] The number of patients with a diagnosis of Bipolar Type I, Type II. and Not Otherwise Specified
Concurrent Medications [1] [2] 
[Units: Number of medications]
 
Participants Analyzed   25 
   4 
[1] Medications currently taken by the patient was provided by the patient.
[2] Based on a list of self-reported failed prior medication treatment trials.
Prior Failed Medication Trials 
[Units: Number of medications]
Mean (Standard Deviation)
 
Participants Analyzed   28 
   14.6  (3.2) 


  Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale (HDRS) -17 Item; Baseline to End of Week 4   [ Time Frame: 4 weeks ]

2.  Secondary:   Beck Depression Inventory Score; Baseline to End of Week 4   [ Time Frame: 4 weeks ]

3.  Secondary:   Clinical Global Impression - Severity; Baseline to End of Week 4   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Hugh Brent Solvason
Organization: Stanford University
phone: 650 776 4793
e-mail: solvason@stanford.edu



Responsible Party: Hugh Brent Solvason, Stanford University
ClinicalTrials.gov Identifier: NCT00186485     History of Changes
Other Study ID Numbers: Stanford 79133
First Submitted: September 14, 2005
First Posted: September 16, 2005
Results First Submitted: October 10, 2016
Results First Posted: June 8, 2017
Last Update Posted: October 6, 2017