Personalized Non-invasive Neuromodulation by rTMS for Chronic and Treatment Resistant Catatonia

NCT03116425 | Unknown

• 1 other identifier: 6441
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators hypothesize that personalizing rTMS targets using functional MRI will allow to improve symptoms of patients suffering from chronic catatonia.

Conditions

Schizophreniform Catatonia; Treatment Resistant

Keywords

Precision Medicine; Functional Neuroimaging; Transcranial Magnetic Stimulation, Repetitive; Transcranial Direct Current Stimulation; Monocentric; Comparative balanced, randomized; double-blind cross-over 3 Arms Study

Outcome Measures

Primary Outcomes (1)

• Clinical global impression (change in severity and improvement)

  Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention

  In term of percentage reduction in symptoms, difference between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)

Secondary Outcomes (11)

• Change in personalized daily visual analogical scales assessing the core symptoms.

  Points results will be averaged over the 4 days before and after each therapeutic arm.

• Change in Bush and Francis Catatonia Rating Scale.

  Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)

• Change in psychosis: PANSS.

  Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)

• Change in depression: Calgary Depression Scale.

  Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)

• Change in apathy: actimetry, apathy inventory and apathy evaluation scale.

  Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)

Other Outcomes (1)

• Change of rCBF anomalies

  Points involvement in scale between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).

Study Arms (3)

Verum 1 - Premotor

EXPERIMENTAL

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.

Device: Individualized rTMS on VERUM 1's region or network; Procedure: Individualized rTMS on VERUM 1's region or network

Verum 2 - Prefrontal

EXPERIMENTAL

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.

Device: Individualized rTMS on VERUM 2's region or network; Procedure: Individualized rTMS on VERUM 2's region or network

Placebo

ACTIVE COMPARATOR

Stimulation of a region with normal rCBF and putatively unrelated to catatonic symptoms (parietal cortex).

Device: Individualized rTMS on PLACEBO region; Procedure: Individualized rTMS on PLACEBO region

Interventions

Individualized rTMS on VERUM 1's region or network DEVICE

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.

Also known as: Putative premotor region or network

Verum 1 - Premotor

Individualized rTMS on VERUM 2's region or network DEVICE

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.

Also known as: Putative prefrontal region or network

Verum 2 - Prefrontal

Individualized rTMS on PLACEBO region DEVICE

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.

Also known as: (One per line)

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 18 to 70 Y
• 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

You may not qualify if:

• Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
• Pregnancy
• Severe and non-stabilized somatic pathology
• Patients deprived of liberty or hospitalized without their consent
• Patients unable to give informed consent.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

CEMNIS

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Catatonia

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Jack FOUCHER, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 17, 2017
• Study Start: April 24, 2017
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)