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Trial record 15 of 36 for:    fmri headache

Improving Functions in MTBI Patients With Headache by rTMS

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ClinicalTrials.gov Identifier: NCT01948947
Recruitment Status : Completed
First Posted : September 24, 2013
Results First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Collaborator:
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition TBI (Traumatic Brain Injury)
Interventions Device: Transcranial Magnetic Stimulation
Device: Sham Transcranial Magnetic Stimulation
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description

Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Period Title: Overall Study
Started 14 15
Completed 14 15
Not Completed 0 0
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation Total
Hide Arm/Group Description

Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 29 participants
36.13  (9.39) 34.43  (7.66) 35.28  (8.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
2
  14.3%
4
  26.7%
6
  20.7%
Male
12
  85.7%
11
  73.3%
23
  79.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   7.1%
0
   0.0%
1
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  14.3%
4
  26.7%
6
  20.7%
White
7
  50.0%
5
  33.3%
12
  41.4%
More than one race
4
  28.6%
6
  40.0%
10
  34.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)
Hide Description The primary outcome time-point measurement will be averaged from each day the subject is enrolled in the study for each of the 3 time point periods: pre-treatment baseline, 1-week follow-up and 1-month follow-up. The results depict change in the composite score: intensity (scale of 0-10) x duration (# of hours) x frequency (# headaches per week). The larger composite score for each subject, the worse the debilitating headaches.
Time Frame Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
1-Week Follow-Up -55.3  (29.0) -1.7  (41.2)
1-Month Follow-Up -58.4  (24.4) -10  (59.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
Comments Change from Baseline to 1-Week Post-Treatment
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
Comments Change from Baseline to 1-Month Post-Treatment
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Percent Change in Persistent Headache Intensity
Hide Description The persistent headache measure was assessed through a daily headache log over the course of the subjects participation in the study and averaged for the time point period of baseline, 1-week and 1-month results. The persistent headache is based on a scale of 0-10, the higher the persistent headache intensity averaged score the worse the persistent headache.
Time Frame Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
1-Week Follow-Up -25.3  (16.8) -1.0  (11.7)
1-Month Follow-Up -22.6  (17.7) -2.3  (14.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Change from Baseline to 1-Week post-treatment
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Change from Baseline to 1-Month post-treatment
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Percent Change in Persistent Headache Prevalence
Hide Description The persistent headache prevalence measure was assessed through a daily headache log over the course of the subjects participation in the study and collected at baseline, 1-week and 1-month. The persistent headache is defined as having had 3+ continuous headaches over the course of the time point periods and was coded as either yes or no. The results indicate the percent change in the prevalence of persistent headaches for the subjects at the time points. A larger reduction percent indicates a larger decrease in subjects with those persistent headaches.
Time Frame Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
1-Week Follow-Up -50  (51) -7  (26)
1-Month Follow-Up -57  (52) -20  (41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Change in Baseline to 1-month post-treatment
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Percent Change in Depression Score From Baseline to 1-Week Post-treatment
Hide Description Subjects assessed how their headaches interfered with their mood through the Hamilton Rating Scale for Depression assessment at baseline, 1-week follow-up and 1-month follow-up. The outcome was measured by adding the score of each question on the assessment and then comparing the averaged scores at the different time points. The larger the depression score, the more severe the depression. A larger percent change in depression score indicates a change in the severity of the depression.
Time Frame Subjects will have a total of 9 visits over the span of 3 months and 3 of those visits will qualify as a time point at which outcome is measured.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: percent change in score from baseline
-14.8  (22.1) -2.7  (40.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.033
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description

Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

All-Cause Mortality
Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Transcranial Magnetic Stimulation Sham Transcranial Magnetic Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/15 (0.00%) 
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 Sham Transcranial Magnetic Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Valerie Metzger Smith, Study Coordinator
Organization: VA San Diego Healthcare System
Phone: 858-750-0274
EMail: valerie.metzgersmith@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01948947     History of Changes
Other Study ID Numbers: F1359-P
H130281 SPiRE rTMS MTBI HA ( Other Identifier: San Diego VA Healthcare System )
First Submitted: September 17, 2013
First Posted: September 24, 2013
Results First Submitted: October 24, 2017
Results First Posted: March 26, 2018
Last Update Posted: March 26, 2018