Expired Study
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Baltimore, Maryland 21224


Purpose:

Traumatic brain injury (TBI) is frequently complicated by depression and other problems such as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and behavioral problems. Untreated depression can lead to reduced productivity and poor global outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of TBI-related depression. The overarching goal of this small study is to determine the effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation technique. It involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. Adults aged 18 and older, with a history of head injury of mild or moderate severity , who are currently experiencing symptoms of clinical depression may join the study.


Criteria:

Inclusion Criteria: 1. Adults aged 18 and over 2. H/o closed head injury 3. Must meet Department of Defense (DoD) criteria for mild or moderate Traumatic Brain Injury (TBI) 4. Must meet criteria for major depression as assessed by the Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual IV (DSM-IV) and a score greater than 10 on the Hamilton Depression 17 (HAM-D17) Scale Exclusion Criteria: 1. Subjects with skull fracture 2. Subjects who meet DoD criteria for severe TBI 3. Subjects who are on psychotropics or mood stabilizing medications (e.g. antidepressants, antipsychotics, anxiolytics, sedative/hypnotics. 4. Subjects who are medically unstable 5. History of active substance abuse x 1 month 6. Current psychotic illness 7. Evidence of frontal lesions on brain scan. 8. Individuals with a significant neurological disorders that could increase risk of seizures such as brain tumor, cerebral aneurysm, any h/o seizures and/or family h/o seizures 9. Dementia 10. Mini Mental State Exam score of less than or equal to 24 11. A positive and unmitigated response to any question on the Transcranial Magnetic Stimulation Safety Screen questionnaire 12. Electroconvulsive therapy (ECT) treatment within 6 months prior to the screening visit 13. History of treatment with rTMS therapy for any disorder 14. History of treatment with Vagus Nerve Stimulation (VNS) 15. History of treatment with Deep Brain Stimulation (DBS) 16. Cardiac pacemakers, implanted medication pumps, intracardiac lines, 17. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. 18. Implanted neurostimulators 19. Known or suspected pregnancy 20. Investigators, personnel affiliated with this study, and their immediate families.


Study is Available At:


Original ID:

NA_00090926


NCT ID:

NCT02367521


Secondary ID:


Study Acronym:

rTMS TBI


Brief Title:

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury


Official Title:

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johns Hopkins University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

70


Enrollment Type:

Actual


Study Dates

Start Date:March 2015
Completion Date:October 1, 2017
Completion Type:Actual
Primary Completion Date:October 1, 2017
Primary Completion Type:Actual
Verification Date:August 2018
Last Changed Date:August 3, 2018
First Received Date:February 9, 2015
First Results Date:July 5, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
Time Frame:Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Safety Issues:False
Description:The HAM-D was used to determine the effectiveness of LFR rTMS for the treatment of post-TBI depression. The scale ranges from 0-54, with 0-7 = Normal; 8-13= Mild Depression; 14-18= Moderate Depression, 19-22= Severe Depression, >/= 23 = Very Severe Dep
Outcome Type:Primary Outcome
Measure:Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
Time Frame:Mean at baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:The CGI scale is broken down into the CGI-S and CGI-I components. CGI-S is the baseline severity of mental illness. 1= normal, not at all ill; 2= borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most ext
Outcome Type:Primary Outcome
Measure:Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
Time Frame:Mean at baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:The BSSI scale is used to assess the degree of suicidal ideation. The scale ranges from 0-38, with 0= no suicidality, and 38 = highest severity of suicidal ideation
Outcome Type:Secondary Outcome
Measure:Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:The SCWT is used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants are required to read three different t
Outcome Type:Secondary Outcome
Measure:Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST)
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of completed
Outcome Type:Secondary Outcome
Measure:Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST)
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of errors, ra
Outcome Type:Secondary Outcome
Measure:Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST)
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of correct tr
Outcome Type:Secondary Outcome
Measure:Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:The Trailmaking B score is the number of seconds spent connecting numbered circles (1-13) to circles containing letters of the alphabet (A-L) in alternating sequential order. A maximum of 300 seconds is allowed. Score ranges from 0-300. Higher score refle
Outcome Type:Secondary Outcome
Measure:Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words
Outcome Type:Secondary Outcome
Measure:Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:The HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to
Outcome Type:Secondary Outcome
Measure:Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each tr
Outcome Type:Secondary Outcome
Measure:Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each tr
Outcome Type:Secondary Outcome
Measure:Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:Trailmaking A is a psychological test with a score that is the number of seconds spent in connecting 25 numbered circles in sequential order. Score ranges from 0-150. Higher score reflects poorer outcome.
Outcome Type:Secondary Outcome
Measure:Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
Time Frame:Baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:The GAD-7 questionnaire is used as a screening tool and severity measure for generalized anxiety disorder. The scale ranges from 0 - 21. 0-4 = normal 5-9 = mild 10-14 = moderate >15 = severe
Outcome Type:Secondary Outcome
Measure:Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
Time Frame:Baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:The DTS is a 17-item self-reported measure that assesses the 17 Diagnostic and Statistical Manual IV (DSM-IV) symptoms of post-traumatic stress disorder (PTSD). Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scale
Outcome Type:Secondary Outcome
Measure:Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
Time Frame:Baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:The PSQI score scale ranges from 0-21. 0 = very good sleep quality 21 = very bad sleep quality A total score of "5" or greater is indicative of poor sleep quality (reflecting a higher level of fatigue)
Outcome Type:Secondary Outcome
Measure:Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
Time Frame:Baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:The ESS is used to determine the level of daytime sleepiness. It is a questionnaire composed of 8 questions. The participant answers each question on a scale of 0 to 3 (0=no sleepiness, 1= mild sleepiness, 2= moderate sleepiness, 3= severe sleepiness). Th
Outcome Type:Secondary Outcome
Measure:Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)
Time Frame:Mean at baseline and 16 weeks
Safety Issues:False
Description:MOCA is designed to assess cognitive impairment and Alzheimer's Disease. It is composed of the following: Visuospatial and Executive Functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed Recall
Outcome Type:Secondary Outcome
Measure:Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
Time Frame:Mean at baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:The NBRS is a 28-item interview which includes a test of orientation and memory for recent events, questions regarding emotional state, post-concussional symptoms, focused attention, and concentration (performing serial sevens), explanation of proverbs, t
Outcome Type:Secondary Outcome
Measure:Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)
Time Frame:Mean at baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:Participants are asked to rate the severity of 16 different symptoms over the past 24 hours, on a severity scale from 0 to 4 (0 = not experienced, 1 = no more of a problem, 2 = mild problem, 3 = moderate problem, 4 = severe problem). The 16 symptoms inclu
Outcome Type:Secondary Outcome
Measure:Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
Time Frame:Mean at baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:The FSS is a 9-item questionnaire which measures the severity of fatigue and how it interferes with certain activities. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The score ranges from 9 to a maximum of 63. A hi
Outcome Type:Secondary Outcome
Measure:Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
Time Frame:Mean at baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:MOAS measures four types of aggressive behavior as witnessed in the past week. Each section consists of five items, with the first section regarding verbal aggression, the second section focusing on aggression against property, the third section measuring
Outcome Type:Secondary Outcome
Measure:Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
Time Frame:Mean at baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:The SWL is a 7-point Likert-style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31
Outcome Type:Secondary Outcome
Measure:Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
Time Frame:Mean at baseline, 4, 8, 12, and 16 weeks
Safety Issues:False
Description:The STC reflects the level of social contact. The score ranges from 0-10, with 0= excellent contact, 10=no contact. A higher score reflects poorer social contact.

Study Interventions

Intervention Type:Combination Product
Name:Low Frequency Right sided repetitive transcranial
Description:LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group. Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
Arm Name:LFR rTMS
Other Name:low frequency right rTMS
Intervention Type:Device
Name:Sham Comparator: Sham Treatment
Description:Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Arm Name:Sham Treatment
Other Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Sham Treatment
Description:Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Study Arm Type:Experimental
Arm Name:LFR rTMS
Description:Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Johns Hopkins University
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:United States Department of Defense

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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