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

Not Applicable

• Conditions: Schizophreniform Catatonia; Treatment Resistant

• Registration Number: NCT03116425
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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

Detailed Description

Two dysfunctional networks or regions will be chosen (verum 1 and 2) based on their abnormal rCBF. In line with the symptoms, dorso-lateral prefrontal and premotor regions are expected to be chiefly concerned. A normal region regarding its rCBF will be used as placebo. Targets will be stimulated using intermittent or continuous theta-burst according to the rCBF anomaly as an attempt to "normalize" their activity. The coil will be positioned using a robotic device under the control of a neuronavigation system in order to deliver a homogeneous stimulation. Using a balanced blinded randomized cross-over design, patients will be stimulated on 5 consecutive days (4 sessions per day) and evaluated pre-, post-stimulation and 1 month after. In this pilot study the primary outcome measures will be the clinical global impression scale whereas MRI will insure that stimulations achieved the correction of the rCBF anomalies. Secondary outcome measures will include personalized target symptom scales, and scales for catatonic, apathic and obsessive-compulsive symptoms.

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-17
• Study Start: 2017-04-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Clinical global impression (change in severity and improvement)	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)	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

Secondary Outcome Measures

Name	Time	Method
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.	This scale has been validated
Change in quality of life for the patient (SF36)	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)	All these scales have been validated.
Change in functioning: WHODAS 2.0.	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)	This scale has been validated.
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)	This scale has been validated.
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)	This scale has been validated.
Change in obsessive compulsive symptoms: Brief Obsessive Compulsive 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)	This scale has been validated.
Change in functioning: Global Assessment of Functioning (GAF 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)	This scale has been validated.
Change in the helping person ("Zarit 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)	This scale has been validated.
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)	This scale has been validated.
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)	This scale has been validated.
Change in obsessive compulsive symptoms: Cambridge-Exeter Repetitive Thought 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)	This scale has been validated.

Trial Locations

Locations (1)

CEMNIS; 🇫🇷 Strasbourg, France