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

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Schizophreniform Catatonia; Treatment Resistant

Treatments: Procedure: Individualized rTMS on PLACEBO region; Procedure: Individualized rTMS on VERUM 2's region or network; Procedure: Individualized rTMS on VERUM 1's region or network

Study type: Interventional

Funder types: Other

Identifiers

NCT03116425

6441

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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17 participants in 3 patient groups

Verum 1 - Premotor

Experimental group

Description:

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.

Treatment:

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

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

Verum 2 - Prefrontal

Experimental group

Description:

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.

Treatment:

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

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

Placebo

Active Comparator group

Description:

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

Treatment:

Procedure: Individualized rTMS on PLACEBO region

Procedure: Individualized rTMS on PLACEBO region