TBI DepressionPhase 2/3rTMS TBINCT02367521
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
A Phase 2/3 study testing Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS) in people with TBI Depression, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI Depression
- What is being tested?
- Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 1 Oct 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 and over
- H/o closed head injury
- Must meet Department of Defense (DoD) criteria for mild or moderate Traumatic Brain Injury (TBI)
- 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
Who cannot join
- Subjects with skull fracture
- Subjects who meet DoD criteria for severe TBI
- Subjects who are on psychotropics or mood stabilizing medications (e.g. antidepressants, antipsychotics, anxiolytics, sedative/hypnotics.
- Subjects who are medically unstable
- History of active substance abuse x 1 month
- Current psychotic illness
Show all 20Show fewer
- Evidence of frontal lesions on brain scan.
- 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
- Dementia
- Mini Mental State Exam score of less than or equal to 24
- A positive and unmitigated response to any question on the Transcranial Magnetic Stimulation Safety Screen questionnaire
- Electroconvulsive therapy (ECT) treatment within 6 months prior to the screening visit
- History of treatment with rTMS therapy for any disorder
- History of treatment with Vagus Nerve Stimulation (VNS)
- History of treatment with Deep Brain Stimulation (DBS)
- Cardiac pacemakers, implanted medication pumps, intracardiac lines,
- 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.
- Implanted neurostimulators
- Known or suspected pregnancy
- Investigators, personnel affiliated with this study, and their immediate families.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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.
- Conditions
- TBI Depression
- Being tested
- Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS), Sham Comparator: Sham Treatment
- Keywords
- TBI Depression, co-morbid psychiatric symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS)Combination product
Also called low frequency right rTMS
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.
Sham Comparator: Sham TreatmentDevice
Also called Placebo
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 group | Role | What they receive |
|---|---|---|
| LFR rTMS | Experimental | 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. Receives: Combination Product: Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS) |
| Sham Treatment | Placebo comparator | 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 Receives: Device: Sham Comparator: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
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 Depression.
Measured: Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
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 extremely ill patients. The CGI-S is only performed at baseline.
The CGI-I component (which is any measure after intervention) is as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Measured: Mean at baseline, 4, 8, 12, and 16 weeks
Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
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
Measured: Mean at baseline, 4, 8, 12, and 16 weeks
Secondary outcomes (21)
Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)
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 tables as fast as possible. Two of the tables represent the "congruous condition" in which participants are required to read names of colors printed in black ink and name different color patches. In the third table, "incongruous condition" the color-words are printed in a different color in (ie: the word "red" is printed in green ink). Within this third table, participants are required to name the color of the ink instead of reading the word. The score is based on the number of items completed, which ranges from 0 to 100, with a higher score reflecting a better outcome.
Measured: Mean at baseline and 16 weeks
Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST)
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 categories, ranging from 0-6. A higher score reflects a better outcome.
Measured: Mean at baseline and 16 weeks
Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST)
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, ranging from 0-128. A higher score reflects a poorer outcome.
Measured: Mean at baseline and 16 weeks
Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST)
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 trials, ranging from 0-128. A higher score reflects a better outcome.
Measured: Mean at baseline and 16 weeks
Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score
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 reflects poorer outcome.
Measured: Mean at baseline and 16 weeks
Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
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. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. The number of correctly-recalled words in each trial is recorded (maximum of 12). The score is a sum of all the correctly-recalled words from each trial, for a maximum score of 36.
Measured: Mean at baseline and 16 weeks
Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
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 the subject at the approximate rate of one word every 2 seconds. This is done for three trials. After the third learning trial, the patient is read 24 words and is asked to say "yes" after each word that appeared on the recall list (12 targets) and "no" after each word that did not (12 distractors). Half of the distractors are drawn from the same semantic categories as the targets (related distractors) and half are drawn from other categories (unrelated distractors). The number of correctly-recalled words in each trial is recorded (maximum of 12 per trial). The score is the sum of all the correctly-recalled words from each trial, for a maximum of 36. T-scores are reported (average T-score of 50 (ranges 40-60)
Measured: Mean at baseline and 16 weeks
Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)
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 trial, participants are to draw as many designs as accurately as they can and in the correct location after a 25-minute delay filled with other distractor tasks. Scoring of the delayed recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial for a total score range of 0-36, with higher scores indicating a better outcome.
Measured: Mean at baseline and 16 weeks
Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)
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 trial, participants are to draw as many designs as accurately as they can and in the correct location. Scoring of the immediate recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial, for a total score ranging from 0-36, with a higher score reflecting a better outcome.
Measured: Mean at baseline and 16 weeks
Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score
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.
Measured: Mean at baseline and 16 weeks
Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
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
Measured: Baseline, 4, 8, 12, and 16 weeks
Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
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 scales (0 = "not at all distressing" to 4 = "extremely distressing").
The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). The severity score will be used to assess this outcome.
Measured: Baseline, 4, 8, 12, and 16 weeks
Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
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)
Measured: Baseline, 4, 8, 12, and 16 weeks
Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
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). The total score is the sum of all responses for a maximum score of 24. A higher score reflects increased sleepiness.
Measured: Baseline, 4, 8, 12, and 16 weeks
Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)
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 (Short-term Memory): 5 points Orientation: 6 points Education Level: 1 point is added to the test-taker's score if he or she has 12 years or less of formal education.
Score ranges 0-31, with ≥ 26 being normal cognitive function. The lower the score, the greater the level of cognitive impairment.
Measured: Mean at baseline and 16 weeks
Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
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, tasks of planning and mental flexibility, and delayed recall of three objects presented at the beginning of a session. Observations are also made regarding the patient's fatigability, visible signs of anxiety, disinhibition, agitation, hostility, difficulties in expressive and receptive communication, and disturbance of mood. The balance of the items are rated according to the patient's performance on brief tasks and quality of answers to interview questions. Each of the 28 items are scored on a scale of 0 (not severe) to 6 (extremely severe), for a maximum score of 168. A higher score reflects increased severity of neuropsychiatric symptoms.
Measured: Mean at baseline, 4, 8, 12, and 16 weeks
Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)
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 include: headaches, dizziness, nausea and/or vomiting, hyperacusis, sleep disturbance, fatigue, being irritable, feeling depressed, feeling frustrated, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision, restlessness. Score ranges from 0 to 64, with a higher score reflecting increased severity of post-concussive symptoms.
Measured: Mean at baseline, 4, 8, 12, and 16 weeks
Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
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 higher score reflects greater fatigue severity.
Measured: Mean at baseline, 4, 8, 12, and 16 weeks
Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
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 autoaggression, and the fourth section concerning physical aggression. Participants are asked to check each item that is true over the last week. Items are allocated 0, 1, 2, 3 or 4 point(s), and then all points for each selected item are summed. The maximum total for each section is 10 if all items are selected. Total score ranges from 0-40 with a higher score indicating more aggressive behavior.
Measured: Mean at baseline, 4, 8, 12, and 16 weeks
Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
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 31-35 indicate the respondent is extremely satisfied.
Measured: Mean at baseline, 4, 8, 12, and 16 weeks
Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
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.
Measured: Mean at baseline, 4, 8, 12, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startMar 2015
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TBI DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367521
- Sponsor's protocol ID
- NA_00090926
- Acronym
- rTMS TBI
- Status last verified
- Aug 2018
- First submitted
- 9 Feb 2015
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT02367521
- Acronym / sponsor ID
- rTMS TBI / NA_00090926
- Conditions
- TBI Depression
- Keywords
- TBI Depression, co-morbid psychiatric symptoms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Mar 2015 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Posted 31 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LFR rTMS | Experimental | Combination Product: Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS)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. |
| Sham Treatment | Placebo comparator | Device: Sham Comparator: Sham TreatmentControl 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 and over
- H/o closed head injury
- Must meet Department of Defense (DoD) criteria for mild or moderate Traumatic Brain Injury (TBI)
- 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
Key exclusion criteria (20 listed)
- Subjects with skull fracture
- Subjects who meet DoD criteria for severe TBI
- Subjects who are on psychotropics or mood stabilizing medications (e.g. antidepressants, antipsychotics, anxiolytics, sedative/hypnotics.
- Subjects who are medically unstable
- History of active substance abuse x 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS)Also: low frequency right rTMSLFR 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. | Combination product | LFR rTMS |
| Sham Comparator: Sham TreatmentAlso: PlaceboControl 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 | Device | Sham Treatment |
Primary outcome
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
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 Depression.
Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
Time frame: Mean at baseline, 4, 8, 12, and 16 weeks
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 extremely ill patients. The CGI-S is only performed at baseline. The CGI-I component (which is any measure after intervention) is as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
Time frame: Mean at baseline, 4, 8, 12, and 16 weeks
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
21 secondary outcomes
Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)
Time frame: Mean at baseline and 16 weeks
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
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
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
Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score
Time frame: Mean at baseline and 16 weeks
Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
Time frame: Mean at baseline and 16 weeks
Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
Time frame: Mean at baseline and 16 weeks
Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)
Time frame: Mean at baseline and 16 weeks
Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)
Time frame: Mean at baseline and 16 weeks
Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score
Time frame: Mean at baseline and 16 weeks
Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
Time frame: Baseline, 4, 8, 12, and 16 weeks
Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
Time frame: Baseline, 4, 8, 12, and 16 weeks
Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
Time frame: Baseline, 4, 8, 12, and 16 weeks
Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
Time frame: Baseline, 4, 8, 12, and 16 weeks
Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)
Time frame: Mean at baseline and 16 weeks
Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
Time frame: Mean at baseline, 4, 8, 12, and 16 weeks
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
Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
Time frame: Mean at baseline, 4, 8, 12, and 16 weeks
Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
Time frame: Mean at baseline, 4, 8, 12, and 16 weeks
Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
Time frame: Mean at baseline, 4, 8, 12, and 16 weeks
Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
Time frame: Mean at baseline, 4, 8, 12, and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS) in people with TBI Depression, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.