Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in Auditory Verbal Hallucinations

NCT05550155 | Recruiting DMC

• 1 other identifier: 21-0157
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) can alleviate persistent auditory verbal hallucinations (AVH) in schizophrenic patients, but the classical procedure with low-frequency stimulation for several weeks upon the left temporoparietal junction have shown modest therapeutic effects, and there is currently no robust predictive factor to the response of the treatment. In a previous multicentric, randomized, and double-blind controlled study, it has been demonstrated that a high-frequency rTMS over an anatomical target can rapidly affect AVHs. Moreover, an intensification of the classical procedure delivering 20-Hz rTMS over a 2-day period was used in addition to a personalized anatomical stimulation target and neuronavigation guidance. Besides the significant efficacy of the procedure, the efficacy was maximal at two weeks after the end of the treatment. In this project, the hypothesis is that the two-day cure could benefit from maintenance rTMS sessions every week for one month and then every two weeks for 3 months to provide an optimal strategy for a long-lasting AVH reduction. This has for now never been tested. Predictive factors to the response of the treatment are also investigated.

Conditions

Schizophrenia; Psychosis

Keywords

Transcranial Magnetic Stimulation; Auditory verbal Hallucination; Neuronavigation

Outcome Measures

Primary Outcomes (1)

• the number of times a patient is assessed as a responder

  the number of times a patient is assessed as a responder in the active versus the sham group during their follow-up between baseline (D1) and at the end of the maintenance treatment (M5), i.e. the month after the last maintenance session.

  between baseline and month 5

Study Arms (2)

sham rTMS

SHAM COMPARATOR

The sham treatment, following the group assignment, will be maintained during the two successive phases of the evaluated protocol. One initial sham rTMS phase will consist of four sham stimulation sessions (20 Hz sham) within two consecutive days. One sham rTMS maintenance phase will consist of two sham stimulation sessions on one day every week for one month and then every two weeks for three months. Clinical data will be assessed by an investigator blind to group assignment until the end of the study. Patients will also be blind to stimulation. A questionnaire will assess the investigator physician and patient beliefs about what group the patient was involved in (placebo group or active group) at the end of the treatment initial phase and at the end of the treatment maintenance phase

Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

active rTMS

EXPERIMENTAL

The active treatment, following the group assignment, will be maintained during the two successive phases of the evaluated protocol. One initial active rTMS phase will consist of four stimulation sessions (20 Hz) within two consecutive days. One active rTMS maintenance phase will consist of two active stimulation sessions on one day every week for one month and then every two weeks for three months.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment DEVICE

a 4-month maintenance procedure of active rTMS

active rTMS

Sham Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

a 4-month maintenance procedure of sham rTMS

sham 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:

• Male or female; Age ≥ 18 years ≤ 65 years
• Diagnosis of schizophrenia or schizoaffective disorders according to DSM 5.0 criteria
• Patients treated with at least one antipsychotic medication
• Presence of auditory verbal hallucinations despite the optimization of the antipsychotic dosage for at least 6 weeks. This will be operationalized by a minimum AHRS score \> 10
• Stable medication dosage for at least 6 weeks before the rTMS treatment
• Patient who understands the French language
• The agreement of the curatorship or tutorship in the case of a protected adult
• Willing to comply with scheduled visits, as outlined in the protocol
• Covered by, or having the right to Social Security or European cover
• Informed and written consent

You may not qualify if:

• Women who are pregnant
• Patients with contraindications for rTMS (history of epilepsy, neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes)
• Patients included or planning to be included in another medical research protocol
• Patients unable to complete the protocol follow-up
• Any brain pathological abnormality known or diagnosed by the cerebral MRI
• Contre-indication for cerebral MRI (metallic fix tooth prosthesis, neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes, severe claustrophobia)

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, 14033, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Hallucinations

Interventions

Transcranial Magnetic Stimulation; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy

Study Officials

• Sonia Dollfus

  University Caen Normandie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Dollfus, MD-PhD

CONTACT

02.31.06.50.18; dollfus-s@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: October 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

FR (1)