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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00531258




Registration number
NCT00531258
Ethics application status
Date submitted
17/09/2007
Date registered
18/09/2007
Date last updated
9/05/2008

Titles & IDs
Public title
TMS in the Treatment of the Sequelae of Closed Brain Injury
Scientific title
The Use of Non Invasive Brain Stimulation in the Treatment of the Sequelae of Closed Brain Injury
Secondary ID [1] 0 0
011007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Closed Head Injury 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Mental Health 0 0 0 0
Depression
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - rTMS
Treatment: Devices - Sham rTMS

Active Comparator: 1 -

Placebo Comparator: 2 -


Treatment: Devices: rTMS
Bilateral rTMS

Treatment: Devices: Sham rTMS
sham rTMS

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Depression Symptom Severity
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Cognitive Tasks
Timepoint [1] 0 0
4 Weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Be aged 18-60 and have capacity to consent

2. Currently meet DSM-IV criteria for a diagnosis of major depressive disorder (expect
for the exclusion of causality by a general medical condition referring to the TBI)
and have the persistence of depressive symptoms for at least one month at sufficient
severity to warrant the diagnosis.

3. Have experienced a closed head injury of mild to moderate severity (Glasgow coma scale
score (GCS) of greater than 8), preceding their depression, and are at least 3 months
post injury. The injury must not have involved specific direct damage to either
frontal lobe.

4. Have a Montgomery Asberg Rating Scale Score of > 20 (moderate - severe depression).
Including only a more severely ill group of subjects limits the placebo response rate.

5. Have had no increase or initiation of new antidepressant (or other psychoactive)
therapy in the 4 weeks prior to enrolment.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have an unstable medical condition, neurological disorder or any history
of a seizure disorder or are currently pregnant or lactating.

2. Patients who have experienced clear structural damage to the left or right
dorsolateral prefrontal cortex as documented on MRI scan

3. Have a current DSM IV diagnosis of alcohol or substance dependence disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Psychiatry Research Centre - Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Depression is very common in people who have experienced a traumatic brain injury. Few
treatments have been found to be effective in treating depression in this situation. We
intend to investigate the effectiveness of a form of brain stimulation, transcranial magnetic
stimulation, which has been found to be effective in treating depression in people who have
not undergone a brain injury. By evaluating new methods of treating depression in this
population, we hope to increase the options available for treating people in this difficult
situation. Furthermore, problems with aspects of thinking are also commonly present post
brain injury, as in some individuals with depression. Various brain stimulation techniques,
including transcranial magnetic stimulation (TMS) have been shown to have a positive effect
on cognition. We also intend to investigate whether a therapeutic effect on cognitive
deficits is present following TMS, in addition to any effects on depression. New treatment
protocols will be developed, and understanding of the pathology and treatment of post
traumatic brain injury depression will be enhanced.
Trial website
https://clinicaltrials.gov/show/NCT00531258
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul B Fitzgerald, MBBS, FRANZCP, PhD
Address 0 0
Alfred Psychiatry Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul B Fitzgerald, MBBS, MPM, FRANZCP, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 9076 6552
Fax 0 0
Email 0 0
p.fitzgerald@alfred.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00531258