Depression
Conditions
Keywords
Transcranial Magnetic Stimulation, Neuronavigation, Magnetic Resonance Imaging
Brief summary
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.
Interventions
DEVICETheta-Burst Stimulation
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.
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
Sponsors
Nottinghamshire Healthcare NHS Trust
Institute of Mental Health Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Beck Depression Inventory scores | 4 weeks |
Other
| Measure | 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 | 4 weeks and 3 months |
Countries
United Kingdom
Outcome results
None listed