Structural and Functional Correlates of Clinical Response to rTMS Treatment in Schizophrenia Patients With Resistant Auditory Hallucinations
TMSCCS
1 other identifier
interventional
45
1 country
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Oct 2015
Longer than P75 for not_applicable schizophrenia
1 active site
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
October 14, 2015
CompletedFirst Submitted
Initial submission to the registry
April 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2025
CompletedFebruary 15, 2024
February 1, 2023
9.9 years
April 22, 2016
February 14, 2024
Conditions
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
- +2 more secondary outcomes
Study Arms (2)
Active Repetitive Transcranial Magnetic Stimulation (rTMS)
ACTIVE COMPARATORlow-frequency (1 Hertz) rTMS
Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
SHAM COMPARATORsham TMS
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unité de Recherche Clinique, EPS Ville Evrard
Neuilly-sur-Marne, 93330, France
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: 31014369DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
Central Study Contacts
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