Structural and Functional Correlates of Clinical Response to rTMS Treatment in Schizophrenia Patients With Resistant Auditory Hallucinations

NCT02755623 | Unknown

• 1 other identifier: dmdpt6tech/mm/2014-A01595-42
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The potential of non-invasive Transcranial Magnetic Stimulation (TMS) as a therapeutic tool for improving schizophrenic symptoms, in particular resistant hallucinations, has been increasingly studied over the past decades. Several studies have demonstrated that low-frequency patterns of repetitive TMS (rTMS) applied over the left Temporoparietal Junction (TPJ), which are known to decrease local activity, significantly reduced auditory verbal hallucinations in schizophrenic patients. In spite of highly promising results, a high level of inter-individual variability in the responses to non-invasive brain stimulation treatments, and the fact that rTMS may prove ineffective in some patients, keep spurring controversy about the efficacy of these approaches (as currently performed), as well as about how to increase its efficacy and consistency. Accordingly, the objectives of this project are to better understand the impact of rTMS on the brains of patients with resistant auditory hallucinations, and to use this information not only to better understand this condition but to develop more efficient and consistent therapies. Thus, in this study, the investigators focus more specifically on resistant auditory hallucinations in schizophrenia, which is a common symptom in schizophrenic patients, and can be treated by rTMS. The investigators hypothesize that there is a baseline difference in anatomical and/or functional connectivity between responder and non-responder patients who are treated with rTMS. Therefore, our project will aim to determine some anatomical and functional connectivity markers of response to rTMS treatment in patients with schizophrenia

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Changes in the integrity of white matter tracts between responder and non-responder patients

  Baseline

• Changes in the variations of the blood-oxygen-dependent level (BOLD) signal between responder and non-responder patients

  Baseline

Secondary Outcomes (7)

• AHRS (Auditory Hallucinations Rating Scale)

  Baseline, 3 weeks, 7 weeks and 15 weeks

• HCS (Hallucinations Change Score)

  Baseline, 3 weeks, 7 weeks and 15 weeks

• PANSS (Positive And Negative Syndrome Scale)

  Baseline, 3 weeks, 7 weeks and 15 weeks

• PSYRATS (Psychotic Symptom Rating Scale)

  Baseline, 3 weeks, 7 weeks and 15 weeks

• BDI (Beck Depression Inventory)

  Baseline, 3 weeks, 7 weeks and 15 weeks

Study Arms (2)

Active Repetitive Transcranial Magnetic Stimulation (rTMS)

ACTIVE COMPARATOR

low-frequency (1 Hertz) rTMS

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

SHAM COMPARATOR

sham TMS

Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

Participants are sequentially randomly assigned to either 20 active rTMS sessions or 20 sham rTMS sessions that were applied over the left temporoparietal junction. Treatments are administered daily, over a period of two weeks.

Active Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a diagnosis of schizophrenia according to DSM-V (Diagnostic and Statistical Manual of Mental Disorder V, 2013) criteria
• Clinically stabilized for at least 3 months
• Patient with resistant auditory hallucinations
• Male or female, 18 to 65 years old
• A written agreement from the patient's legal guardian/s, if applicable
• Right-handed
• A good knowledge of the French language
• Signed consent form

You may not qualify if:

• Other diseases than schizophrenia
• Indulging in an addiction (alcohol, psychoactive substances) over the last 12 months
• Patient who has received rTMS treatment in the last 12 months
• Patient who is participating in a concurrent research protocol
• Patient with a history of seizures
• rTMS contraindications: patient with epilepsy, brain surgery and/or head trauma in the past, use of cardiac pacemaker, or surgical staples on the scalp
• MRI contraindications: pregnancy or lactating (n.b. a negative pregnancy test will be required if the patient is a female in reproductive years who does not use contraception); use of cardiac pace maker or surgical staples; patient with a neurological disorder, head trauma or claustrophobia
• Patient with severe cardiovascular disease
• Patient with medication which reduces the epileptic threshold (bupropion, methadone and theophylline)
• Patients placed in psychiatric care either by the state or a third party

Sponsors & Collaborators

• Centre hospitalier de Ville-Evrard, France: lead

Study Sites (1)

Unité de Recherche Clinique, EPS Ville Evrard

Neuilly-sur-Marne, 93330, France

RECRUITING

Related Publications (1)

• Thomas F, Bouaziz N, Gallea C, Schenin-King Andrianisaina P, Durand F, Bollore O, Benadhira R, Isaac C, Braha-Zeitoun S, Moulier V, Valero-Cabre A, Januel D. Structural and functional brain biomarkers of clinical response to rTMS of medication-resistant auditory hallucinations in schizophrenia patients: study protocol for a randomized sham-controlled double-blind clinical trial. Trials. 2019 Apr 23;20(1):229. doi: 10.1186/s13063-019-3311-x.

  PMID: 31014369 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Fanny Thomas, BIOLOGISTE

  Unité de Recherche Clinique, EPS Ville Evrard, Neuilly-sur-Marne,, France, 93330

  PRINCIPAL INVESTIGATOR

• Dominique Januel, MD, PhD

  Unité de Recherche Clinique, EPS Ville Evrard, Neuilly-sur-Marne,, France, 93330

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arezki Ourrad

CONTACT

+33143093232; urcve1@gmail.com

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: PRINCIPAL INVESTIGATOR
• PI Title: head of research center and clinical professor

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 29, 2016
• Study Start: October 14, 2015
• Primary Completion: September 8, 2025
• Study Completion: October 8, 2025
• Last Updated: February 15, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)