NCT02479919

Brief Summary

The purpose of the study is to test a new treatment of social cognition deficits in patients with schizophrenia or schizoaffective disorder by transcranial magnetic stimulation (theta-burst). The study will also identify clinical, psychomotor and cognitive variables that are the most sensitive to treatment, and estimate the most sensitive treatment target between patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 11, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

5.9 years

First QC Date

June 2, 2015

Last Update Submit

March 8, 2022

Conditions

Social Cognition in Patients With Schizophrenia

Keywords

theta burst stimulationSocial CognitionSchizophreniatranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • V-LIS total score

    change from baseline in V-LIS total score compared to 30 days after the end of the treatment

Secondary Outcomes (1)

  • Motor activity measured with an actimeter

    change in baseline motor activity measured with an actimeter compared to 30 days after the end of the treatment

Study Arms (3)

TBS-MPC

EXPERIMENTAL

Intervention with Magstim® Active TBS aiming Medial Prefrontal Cortex in 18 patients with schizophrenia

Device: Magstim® Active TBS

TBS-CPDLF

ACTIVE COMPARATOR

Intervention with Magstim® Active TBS aiming Dorsolateral Prefrontal Cortex in 18 patients with schizophrenia

Device: Magstim® Active TBS

TBS-Sham

SHAM COMPARATOR

Intervention with Magstim® Sham TBS in 25 patients with schizophrenia

Device: Magstim® Sham TBS

Interventions

Magstim® Active TBSDEVICE

Non-invasive transcranial magnetic stimulation inducing changes in cortical excitability depending on the cortical target (except for sham stimulation)

TBS-CPDLFTBS-MPC
Magstim® Sham TBSDEVICE

Sham stimulation

TBS-Sham

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • with a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV MINI R)
  • Having signed a written informed consent
  • 'Lecture Intentionnelle en situation' (LIS) score \> 15 or negative 'Positive and Negative Syndrome Scale' (PANSS) score \> 15

You may not qualify if:

  • Pregnant or breastfeeding women
  • Subjects with a neurological condition or with epilepsy
  • Subjects with a counter-indication to MRI or Transcranial stimulation (electronic or metal implants)
  • Subjects that refuse to wear earplugs during MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dollfus

Caen, 14000, France

RECRUITING

Jaafari

Poitiers, France

RECRUITING

Guillin

Sotteville-lès-Rouen, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Sonia Dollfus, Pr

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Dollfus, Pr

CONTACT

(0)231065018dollfus@cyceron.fr

Céline Margrite

CONTACT

(0)231065018margrite-c@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 24, 2015

Study Start

April 11, 2017

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

FR(3)