Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression
NCT ID: NCT02740244
Last Updated: 2018-08-02
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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TERMINATED
NA
20 participants
INTERVENTIONAL
2011-01-31
2015-01-31
Brief Summary
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Detailed Description
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Depression severity will be assessed by an investigator blinded to iTBS condition before and after 10 to 30 iTBS sessions depending on remission onset. Remission will be defined as Beck Depression Inventory, BDI score\<10.
Objective/Hypothesis: The investigators hypothesized the superiority of active iTBS over sham ITBS
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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active iTBS
Participants will receive 10 to 30 sessions of active intermittent theta burst stimulation (iTBS) consisting in delivering 2 s train of bursts containing three pulses at 50 Hz repeated each 200 ms every 10 s (iTBS). Each iTBS session contained 990 pulses and lasted 6 min. Stimulation intensity will be set at 80% of the patient's resting motor threshold. iTBS will be applied twice per day, with at least three hours between each session. Ten to 30 sessions will be delivered until patient achieved remission (i.e., 13-item Beck Depression Inventory (BDI13) score \< 10). iTBS will be applied over the left dorsolateral prefrontal cortex (DLPFC) according to the individual's 3D-T1 MRI.
active iTBS
Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a figure-eight coil (MCF-B65)
sham iTBS
The same protocol (location, intensity, parameters of stimulation) will be applied using a commercial sham coil.
sham iTBS
Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a sham figure-eight coil (MCF-P-B65)
Interventions
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active iTBS
Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a figure-eight coil (MCF-B65)
sham iTBS
Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a sham figure-eight coil (MCF-P-B65)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Montgomery and Asberg depression scale \> 20
Exclusion Criteria
* Benzodiazepines intake
* pregnancy
18 Years
65 Years
ALL
No
Sponsors
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Hôpital le Vinatier
OTHER
Responsible Party
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Principal Investigators
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David Szekely, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Other Identifiers
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1018 rTMS DEP BIP
Identifier Type: -
Identifier Source: org_study_id
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