TMS in the Treatment of the Sequelae of Closed Brain Injury

NCT00531258 | Completed

• 1 other identifier: 011007
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Closed Head Injury

Keywords

Depression; TBI; TMS; Major Depression resulting from a mild to moderate closed head injury

Outcome Measures

Primary Outcomes (1)

• Depression Symptom Severity

  4 weeks

Secondary Outcomes (1)

• Cognitive Tasks

  4 Weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Device: rTMS

2

PLACEBO COMPARATOR

Device: Sham rTMS

Interventions

rTMS DEVICE

Bilateral rTMS

1

Sham rTMS DEVICE

sham rTMS

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be aged 18-60 and have capacity to consent
• 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.
• 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.
• Have had no increase or initiation of new antidepressant (or other psychoactive) therapy in the 4 weeks prior to enrolment.

You may not qualify if:

• Patients who have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating.
• Patients who have experienced clear structural damage to the left or right dorsolateral prefrontal cortex as documented on MRI scan
• Have a current DSM IV diagnosis of alcohol or substance dependence disorder.

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

Alfred Psychiatry Research Centre

Prahran, Victoria, 3181, Australia

Location

MeSH Terms

Conditions

Depression; Head Injuries, Closed

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Paul B Fitzgerald, MBBS, FRANZCP, PhD

  Alfred Psychiatry Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: January 1, 2008
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

AU (1)