TMS Treatment for Depression in the National Health Service

Study Overview
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Brief Summary
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This research programme purports to test the effectiveness of two Transcranial Magnetic Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI) scans to improve the localization of TMS targets.

Official Title
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An Evaluation of Transcranial Magnetic Stimulation in the National Health Service

Conditions
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Depression

Intervention / Treatment
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* Device: Theta-Burst Stimulation
* Device: High frequency stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of depressive disorder (DSM-IV) Diagnosis of treatment resistance (at least stage 1 as defined by Thase & Rush, 1997 for depression) Female or male between 18 and 70 years Exclusion Criteria: History of Bipolar disorder Clinically relevant neurological comorbidity such as brain neoplasm, cerebral vascular events, epilepsy, neurodegenerative disorders, prior brain surgery Metal objects in and around body that cannot be removed Pregnancy Cardiac pacemaker or implanted medication pump Major unstable medical illness Change in prescribed medication in the 2 weeks preceding the start of TMS trial Current alcohol/stimulant dependence with propensity for toxic/withdrawal seizures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theta-Burst Stimulation<br>Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging) | Device: Theta-Burst Stimulation<br>* At 80% motor threshold determined using single pulse stimuli. Depending on the hemisphere determined by connectivity analysis and neuronavigation in each individual, either continuous (left prefrontal) or intermittent (right prefrontal) train of pulses will be delivered.<br>|
| Active Comparator: High Frequency stimulation<br>High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex. | Device: High frequency stimulation<br>* Left prefrontal stimulation. 120% motor threshold with a pulse sequence of 10 Hz for 4 seconds, followed by a 26 second quiet period. Treatment will last for a total of 37.5 minutes this is a total of 3,000 pulses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Beck Depression Inventory scores |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation, Neuronavigation, Magnetic Resonance Imaging