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Trial record 97 of 157 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND traumatic brain injury (TBI)

rTMS to Improve Cognitive Function in TBI (rTMSTBI)

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.
 
ClinicalTrials.gov Identifier: NCT02152540
Recruitment Status : Completed
First Posted : June 2, 2014
Results First Posted : May 7, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Traumatic Brain Injury
Interventions Device: rTMS
Device: Sham rTMS
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title rTMS Sham rTMS
Hide Arm/Group Description

Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.

Sham rTMS: Placebo Device that simulates active rTMS treatment

Period Title: Overall Study
Started 17 16
Completed 17 16
Not Completed 0 0
Arm/Group Title rTMS Sham rTMS Total
Hide Arm/Group Description

Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.

Sham rTMS: Placebo Device that simulates active rTMS treatment

Total of all reporting groups
Overall Number of Baseline Participants 17 16 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
16
 100.0%
33
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 16 participants 33 participants
49.4  (13.3) 39.4  (11.9) 44.4  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Female
5
  29.4%
0
   0.0%
5
  15.2%
Male
12
  70.6%
16
 100.0%
28
  84.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.9%
0
   0.0%
1
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   6.3%
1
   3.0%
Black or African American
1
   5.9%
2
  12.5%
3
   9.1%
White
11
  64.7%
8
  50.0%
19
  57.6%
More than one race
3
  17.6%
4
  25.0%
7
  21.2%
Unknown or Not Reported
1
   5.9%
1
   6.3%
2
   6.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 17 participants 16 participants 33 participants
17
 100.0%
16
 100.0%
33
 100.0%
Trails B T-score   [1] 
Mean (Standard Deviation)
Unit of measure:  T-score
Number Analyzed 17 participants 16 participants 33 participants
52.1  (8.2) 45.3  (14.9) 48.7  (11.6)
[1]
Measure Description: T-score for Trails B task measuring Executive Function: minimum of 0 and a maximum of 100
1.Primary Outcome
Title Trail Making Test Part B
Hide Description

The primary hypothesis is that Veterans receiving active rTMS will show improvement more than sham treated Veterans in performance between baseline and last assessment of >1 SD on the Trail Making Test part B. This test is known for its accurate assessment of executive function in mild and moderate TBI.

The TMT is a timed test and the goal is to complete the test as accurately and as quickly as possible. Raw scores are reported in seconds to complete the test. For Part B, an average score is 75 seconds and a deficient score is greater than 273 seconds.

The present study reports T-scores, which can range from a minimum of 0 and a maximum of 100. The higher the T- score achieved by a participant, the better the performance, indicating a higher level of functioning.

Time Frame Baseline (up to two weeks after screening visit); Post-Treatment (2 weeks from end of Baseline up to one month from entering the study but always the day of last treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rTMS Sham rTMS
Hide Arm/Group Description:

Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.

Sham rTMS: Placebo Device that simulates active rTMS treatment

Overall Number of Participants Analyzed 17 16
Mean (Standard Error)
Unit of Measure: T-score
Baseline 52.1  (14.9) 45.3  (13.7)
post-treatment 52.9  (8.2) 50.8  (10.3)
2.Secondary Outcome
Title Sustained Improvement on Executive Function
Time Frame 6-month post treatment follow up
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Quality of Life (QOL) Scale
Hide Description The Veterans RAND 36 Item Health Survey (VR-36©) is a brief, generic, multi-use, self-administered health surveys comprised of 36 items The instruments are primarily used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue , social functioning and mental health. higher scores mean better health and depicted in percentages. This scale would show significantly greater improvement in patients with mild to moderate TBI who received rTMS treatment.
Time Frame One month
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Moderators of Response
Hide Description Moderators of response such as age, severity of symptoms at baseline, time to injury, type of comorbidity, PTSD, sleep depression, substance abuse, medication use, cognitive exercises, fatigue, TBI type, duration of illness, prior treatment resistance (rTMS/ECT) or any combination of these, may affect or moderate the treatment response.
Time Frame one month
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Functional Brain Connectivity
Hide Description Greater functional connectivity will be observed in hub centers of the Default Mode Network (DMN), particularly the precuneus/posterior cingulate area as measured by resting state fMRI/diffusion tensor imaging (DTI) at follow up compared to baseline in those TBI patients treated with rTMS compared to those treated with sham.
Time Frame Six month follow-up
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Mediators of Response
Hide Description Mediators of response to treatment: to establish a preliminary understanding of the underlying mechanisms related to rTMS modulation of synaptic repair in TBI we will also look at brain-derived neurotrophic factor (BDNF) samples in our population.
Time Frame 6 month follow up
Outcome Measure Data Not Reported
Time Frame 6 months (from first rTMS treatment to 6 month follow up)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rTMS Sham rTMS
Hide Arm/Group Description

Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.

rTMS: Repetitive Transcranial Magnetic Stimulation

Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.

Sham rTMS: Placebo Device that simulates active rTMS treatment

All-Cause Mortality
rTMS Sham rTMS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
rTMS Sham rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
rTMS Sham rTMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/17 (35.29%)      0/16 (0.00%)    
Ear and labyrinth disorders     
Sensation of decreased hearing acuity, pt realized was more "aware" of hearing *  1/17 (5.88%)  1 0/16 (0.00%)  0
Endocrine disorders     
hematoma at surgery site after parathyroidectomy, unrelated to study participation *  1/17 (5.88%)  1 0/16 (0.00%)  0
Eye disorders     
Pain behind R eye for 5 minutes *  1/17 (5.88%)  1 0/16 (0.00%)  0
Pressure behind eyes and headache starting after baseline MRI, resolved in 3 days during first treat *  1/17 (5.88%)  1 0/16 (0.00%)  0
Stimulation-induced eye lid and facial twitching due to improper coil positioning, resolved in secs *  1/17 (5.88%)  1 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Exacerbation of low back pain, resolved in 3 days w medication *  1/17 (5.88%)  1 0/16 (0.00%)  0
Vascular disorders     
Headache after treatment, resolved same day w/out treatment *  1/17 (5.88%)  1 0/16 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Maheen M. Adamson
Organization: DVBIC, VA Palo Alto/Stanford School of Medicine
Phone: 6502136307
EMail: madamson@stanford.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02152540     History of Changes
Other Study ID Numbers: N1416-P
RX13-011 ( Other Grant/Funding Number: VA Rehab )
First Submitted: May 22, 2014
First Posted: June 2, 2014
Results First Submitted: February 6, 2019
Results First Posted: May 7, 2019
Last Update Posted: August 14, 2019