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| Name | Class |
|---|---|
| Nottinghamshire Healthcare NHS Trust | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theta-Burst Stimulation | Experimental | Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging) |
|
| High Frequency stimulation | Active Comparator | High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theta-Burst Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Beck Depression Inventory scores | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in processing speed (using modified digit-symbol test) scores | 4 weeks and 3 months | |
| Change in Clinical Global Impression scores | 4 weeks and 3 months | |
| Change in Social and Occupational Functioning Assessment scores |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudheer Lankappa, MRCPsych | Nottinghamshire Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust | Nottingham | England | NG2 7UH | United Kingdom |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| High frequency stimulation | Device | 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 |
|
| 4 weeks and 3 months |