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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Personalized Non-invasive Neuromodulation by rTMS for Chronic and Treatment Resistant Catatonia - A Proof of Concept Study

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

Detailed Summary: 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.
Sponsor: University Hospital, Strasbourg, France

Current Primary Outcome: Clinical global impression (change in severity and improvement) [ Time Frame: 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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in personalized daily visual analogical scales assessing the core symptoms. [ Time Frame: Points results will be averaged over the 4 days before and after each therapeutic arm. ]
    This scale has been validated
  • Change in Bush and Francis Catatonia Rating Scale. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 quality of life for the patient (SF36) [ Time Frame: 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 the helping person ("Zarit scale") [ Time Frame: 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) [ Time Frame: 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: WHODAS 2.0. [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: University Hospital, Strasbourg, France

Dates:
Date Received: March 22, 2017
Date Started: April 24, 2017
Date Completion: December 30, 2020
Last Updated: May 11, 2017
Last Verified: April 2017