Personalized Non-invasive Neuromodulation by rTMS for Chronic and Treatment Resistant Catatonia
NCT ID: NCT03116425
Last Updated: 2022-04-20
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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UNKNOWN
NA
17 participants
INTERVENTIONAL
2017-04-24
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Verum 1 - Premotor
The target region will be defined by comparing the rCBF scan of the patient to a control population (n = 38). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio.
The network including the premotor region will be targeted. The therapeutic protocol will be design to correct the rCBF anomaly.
Individualized rTMS on VERUM 1's region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on VERUM 1's region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Verum 2 - Prefrontal
The target region will be defined by comparing the rCBF scan of the patient to a control population (n = 38). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio.
The network including the prefrontal region will be targeted. The therapeutic protocol will be design to correct the rCBF anomaly.
Individualized rTMS on VERUM 2's region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on VERUM 2's region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Placebo
Stimulation of a region with normal rCBF and putatively unrelated to catatonic symptoms (parietal cortex).
Individualized rTMS on PLACEBO region
Region will be modulated up or down according to the stimulation protocol used in VERUM 1 and 2 conditions.
Stimulation will be replicated up to 5 times per session. Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on PLACEBO region
Region will be modulated up or down according to the stimulation protocol used in VERUM 1 and 2 conditions.
Stimulation will be replicated up to 5 times per session. Patients will have 4 sessions per day on 5 successive days per arm.
Interventions
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Individualized rTMS on VERUM 1's region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on VERUM 2's region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on PLACEBO region
Region will be modulated up or down according to the stimulation protocol used in VERUM 1 and 2 conditions.
Stimulation will be replicated up to 5 times per session. Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on VERUM 1's region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on VERUM 2's region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on PLACEBO region
Region will be modulated up or down according to the stimulation protocol used in VERUM 1 and 2 conditions.
Stimulation will be replicated up to 5 times per session. Patients will have 4 sessions per day on 5 successive days per arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Affiliated to the health insurance
* Having signed an informed consent
* Suffering from catatonia according to the DSM5, unremitted since \> 2Y
* Unresponsive or incomplete remission after at least one trial of benzodiazepine and/or Electroconvulsivotherapy
* Treatment stable for \> 6 weeks
Exclusion Criteria
* Pregnancy
* Severe and non-stabilized somatic pathology
* Patients deprived of liberty or hospitalized without their consent
* Patients unable to give informed consent.
18 Years
70 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Jack FOUCHER, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Locations
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CEMNIS
Strasbourg, , France
Countries
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Other Identifiers
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6441
Identifier Type: -
Identifier Source: org_study_id
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