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Repetitive Transcranial Magnetic Stimulation for Treating Depression: A Functional Magnetic Resonance Imaging Study

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ClinicalTrials.gov Identifier: NCT01162382
Recruitment Status : Terminated (Grant support ended following which the key personnel (PI) left the institution.)
First Posted : July 14, 2010
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Major Depressive Disorder
Intervention Device: Transcranial Magnetic Stimulation
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transcranial Magnetic Stimulation
Hide Arm/Group Description

Open-label transcranial magnetic stimulation

Transcranial Magnetic Stimulation: Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.

Period Title: Overall Study
Started [1] 0
Completed [1] 0
Not Completed 0
[1]
No data are available fo this study as the study was terminated and PI has left the institution.
Arm/Group Title Transcranial Magnetic Stimulation
Hide Arm/Group Description

Open-label transcranial magnetic stimulation

Transcranial Magnetic Stimulation: Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.

Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
No data are available for this study as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants
1.Primary Outcome
Title Hamilton Depression Rating Scale-24 Point Version (HDRS-24)
Hide Description HDRS-24 will be used to measure response to rTMS treatment. A 50% decrease in HDRS-24 score will indicate treatment response; HDRS-24 < 10 will indicate remission.
Time Frame At study entry and within 2 days of exiting 4 weeks of rTMS treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No data are available for this study as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.
Arm/Group Title Transcranial Magnetic Stimulation
Hide Arm/Group Description:

Open-label transcranial magnetic stimulation

Transcranial Magnetic Stimulation: Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title fCMRI Results
Hide Description Imaging studies will be compared to determine if any changes in functional connectivity can be correlated with treatment response.
Time Frame At study entry and within 2 days of exiting 4 weeks of rTMS treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No data are available for this study as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.
Arm/Group Title Transcranial Magnetic Stimulation
Hide Arm/Group Description:

Open-label transcranial magnetic stimulation

Transcranial Magnetic Stimulation: Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame No data are available for this study as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.
Adverse Event Reporting Description No data are available for this study as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.
 
Arm/Group Title Transcranial Magnetic Stimulation
Hide Arm/Group Description

Open-label transcranial magnetic stimulation

Transcranial Magnetic Stimulation: Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.

All-Cause Mortality
Transcranial Magnetic Stimulation
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Transcranial Magnetic Stimulation
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transcranial Magnetic Stimulation
Affected / at Risk (%)
Total   0/0 
No data are available for this study as the study was terminated and PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kathy Pierce
Organization: Washington University School of Medicine
Phone: 314-362-5626
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01162382     History of Changes
Other Study ID Numbers: WUSM3621222-201110079
First Submitted: November 30, 2009
First Posted: July 14, 2010
Results First Submitted: February 8, 2019
Results First Posted: February 18, 2019
Last Update Posted: February 18, 2019