TMS Treatment for Depression in the National Health Service
NCT ID: NCT02016456
Last Updated: 2017-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2014-10-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Theta-Burst Stimulation
Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)
Theta-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.
High Frequency stimulation
High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex.
High frequency stimulation
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
Interventions
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Theta-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.
High frequency stimulation
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Nottinghamshire Healthcare NHS Trust
OTHER_GOV
Institute of Mental Health Nottingham
OTHER
Responsible Party
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Sudheer Lankappa
Consultant Psychiatrist
Principal Investigators
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Sudheer Lankappa, MRCPsych
Role: PRINCIPAL_INVESTIGATOR
Nottinghamshire Healthcare NHS Trust
Locations
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Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust
Nottingham, England, United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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AMH/021213
Identifier Type: -
Identifier Source: org_study_id
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