Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Reducing Auditory Verbal Hallucinations (AVH) With High Frequency and Neuronavigation Guidance: A Double-blind, Randomized and Multicentric Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Caen University Hospital
RECRUITING
Caen
Contact Information
Primary
Sonia Dollfus, MD-PhD
dollfus-s@chu-caen.fr
02.31.06.50.18
Time Frame
Start Date: 2023-10-30
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 120
Treatments
Sham_comparator: sham rTMS
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
Experimental: active rTMS
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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Caen

This content was sourced from clinicaltrials.gov