Treatment Resistant Clinical Trial
— RETONICOfficial title:
Personalized Non-invasive Neuromodulation by rTMS for Chronic and Treatment Resistant Catatonia - A Proof of Concept Study
Verified date | April 2022 |
Source | University Hospital, Strasbourg, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators hypothesize that personalizing rTMS targets using functional MRI will allow to improve symptoms of patients suffering from chronic catatonia.
Status | Active, not recruiting |
Enrollment | 17 |
Est. completion date | June 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion criteria: - 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 Exclusion criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | CEMNIS | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of rCBF anomalies | 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 average of 2 ยท 3 (=6) measures of rCBF using QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. We will compare the rCBF change of the target region before and after the therapeutic protocol between the different procedures (ANOVA). | 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). | |
Primary | 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 | Change in personalized daily visual analogical scales assessing the core symptoms. | This scale has been validated | Points results will be averaged over the 4 days before and after each therapeutic arm. | |
Secondary | Change in Bush and Francis Catatonia Rating Scale. | This scale has been validated. | 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) | |
Secondary | Change in psychosis: PANSS. | This scale has been validated. | 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) | |
Secondary | Change in depression: Calgary Depression Scale. | This scale has been validated. | 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) | |
Secondary | Change in apathy: actimetry, apathy inventory and apathy evaluation scale. | This scale has been validated. | 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) | |
Secondary | Change in obsessive compulsive symptoms: Brief Obsessive Compulsive Scale | This scale has been validated. | 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) | |
Secondary | Change in obsessive compulsive symptoms: Cambridge-Exeter Repetitive Thought Scale. | This scale has been validated. | 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) | |
Secondary | Change in quality of life for the patient (SF36) | All these scales have been validated. | 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) | |
Secondary | Change in the helping person ("Zarit scale") | This scale has been validated. | 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) | |
Secondary | Change in functioning: Global Assessment of Functioning (GAF scale) | This scale has been validated. | 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) | |
Secondary | Change in functioning: WHODAS 2.0. | This scale has been validated. | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Phase 2 |