NCT02440867

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 variables, cognitive and psychomotor most sensitive to treatment, to estimate the most sensitive treatment target, assess tolerance, to assess the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on the brain a multimodal imaging study and compare the imaging variables (resting network, Diffusion Tensor Imaging, magnetic resonance spectroscopic imaging; MRSI) between patients before treatment and healthy subjects.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2.6 years

First QC Date

May 4, 2015

Last Update Submit

July 19, 2017

Conditions

Social Cognition in Patients With Schizophrenia

Keywords

theta burst stimulationSocial CognitionMRSISchizophreniatranscranial 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 (3)

  • GLX ratio

    change in baseline GLX ratio measured in MRSI compared to 30 days after the end of the treatment

  • P50 wave amplitude

    change in baseline P50 amplitude compared to immediately after the end of the treatment

  • Motor activity

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

Study Arms (4)

Healthy subjects

NO INTERVENTION

Multimodal imaging data acquisitions Clinical data acquisitions

TBS-MPC

EXPERIMENTAL

* Intervention with active TBS aiming Medial Prefrontal Cortex in 6 patients with schizophrenia * Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Continuous actimetry acquisition

Device: Active TBS

TBS-CPDLF

ACTIVE COMPARATOR

* Intervention with active TBS aiming Dorsolateral Prefrontal Cortex in 6 patients with schizophrenia * Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Continuous actimetry acquisition

Device: Active TBS

TBS-Sham

SHAM COMPARATOR

* Intervention with Sham TBS in 8 patients with schizophrenia * Baseline: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Endpoint: Multimodal imaging data acquisitions; Clinical data acquisitions; P50 acquisition * Continuous actimetry acquisition

Device: Sham TBS

Interventions

Active TBSDEVICE

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

TBS-CPDLFTBS-MPC
Sham TBSDEVICE

Sham stimulation

TBS-Sham

Eligibility Criteria

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

You may qualify if:

  • with a diagnosis of schizophrenia or schizoaffective disorder (DSM-IV MINI R)
  • less than 20 years of disease duration
  • Having signed a written informed consent
  • LIS score \> 15 or negative 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 (1)

CHU de Caen - Centre Esquirol

Caen, 14033, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Clément Nathou, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clement Nathou, MD

CONTACT

(0)231065018nathou@chu-caen.fr

Sonia Dollfus, MD, PhD

CONTACT

(0)231065018dollfus@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

May 4, 2015

First Posted

May 12, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

FR(1)