Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPsychiatric University Hospital, Zurich
About this trial
Auditory verbal hallucinations (AVH), such as hearing voices in the absence of an external sound source, are a common and distressing symptom of schizophrenia. In some patients, hallucinations persist despite treatment with antipsychotic medication. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that may reduce auditory hallucinations by decreasing activity in brain regions involved in auditory and language processing.
This randomized, double-blind, sham-controlled study will investigate whether individualized, neuronavigated inhibitory rTMS can reduce persistent auditory verbal hallucinations. Forty adults with medication-resistant auditory hallucinations will be randomly assigned to receive either active rTMS or sham stimulation.
For each participant, the stimulation target in the primary auditory cortex will be individually identified using electroencephalography (EEG), acoustic evoked potentials, and magnetic resonance imaging (MRI)-based neuronavigation. Participants will receive two rTMS sessions per day for five consecutive days. The severity of auditory hallucinations will be assessed before and after treatment and at a 28-day follow-up.
The study will also investigate whether treatment is associated with changes in brain activity and functional connectivity measured by EEG, including changes in the P300 event-related potential.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent provided prior to participation
Age 18 to 65 years
At least two adequate trials of antipsychotic medication
At least one of these trials with an atypical antipsychotic medication
Disqualifiers
Contraindications to TMS treatment, including cochlear implants, metallic devices close to the TMS coil, history of stroke, head injury, or seizures/epilepsy
History of epileptic convulsive seizures or epileptiform potentials in previous EEG examinations
TMS treatment within the 3 months preceding study inclusion
Known severe hypersensitivity or severe adverse reaction to TMS
Trial design
Design model
Parallel
Treatments tested in this trial
Neuronavigated repetitive transcranial magnetic stimulation (rTMS)
DeviceIndividualized neuronavigated inhibitory rTMS is applied to the primary auditory cortex. The individual stimulation target is determined using EEG-based auditory evoked potentials and MRI-based neuronavigation. Stimulation is delivered at 1 Hz on five consecutive days, with a total of 12,000 magnetic pulses administered over the treatment course.
Sham repetitive transcranial magnetic stimulation (rTMS)
DeviceSham stimulation is administered using the same neuronavigation procedures and treatment schedule as active rTMS. A sham coil visually and acoustically resembling the active coil is used but does not deliver active magnetic stimulation.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active rTMSExperimental treatment 1 intervention
Group B: Sham rTMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Auditory Vocal Hallucination Rating Scale (AVHRS) Score Immediately After Treatment
Change from baseline in auditory hallucination severity assessed with the Auditory Vocal Hallucination Rating Scale (AVHRS), a structured interview assessing multiple characteristics of auditory hallucinations, including frequency, duration, location, loudness, negative content, distress, interference with daily life, perceived control, anxiety, and interference with thinking.
Time frame
Baseline to immediately after completion of the 5-day treatment periodSecondary outcomes
1
Change From Baseline in Auditory Vocal Hallucination Rating Scale (AVHRS) Score at Day 28
Change from baseline in auditory hallucination severity assessed with the Auditory Vocal Hallucination Rating Scale (AVHRS), a structured interview assessing multiple characteristics of auditory hallucinations, including frequency, duration, location, loudness, negative content, distress, interference with daily life, perceived control, anxiety, and interference with thinking.
Time frame
Baseline to Day 28 after completion of treatment2
Change From Baseline in PSYRATS Auditory Hallucinations Subscale Score Immediately After Treatment
Change from baseline in the Auditory Hallucinations subscale of the Psychotic Symptom Rating Scales (PSYRATS). The subscale consists of 11 items scored from 0 to 4, yielding a total score from 0 to 44. Higher scores indicate greater auditory hallucination severity.
Time frame
Baseline to immediately after completion of the 5-day treatment period3
Change From Baseline in PSYRATS Delusions Subscale Score Immediately After Treatment
Change from baseline in the Delusions subscale of the Psychotic Symptom Rating Scales (PSYRATS). The subscale consists of 6 items scored from 0 to 4, yielding a total score from 0 to 24. Higher scores indicate greater delusion severity.
Time frame
Baseline to immediately after completion of the 5-day treatment period4
Change From Baseline in PSYRATS Combined Score Immediately After Treatment
Change from baseline in the combined Psychotic Symptom Rating Scales (PSYRATS) score, calculated as the sum of the Auditory Hallucinations and Delusions subscale scores. The combined score ranges from 0 to 68, with higher scores indicating greater overall psychotic symptom severity.
Time frame
Baseline to immediately after completion of the 5-day treatment periodSponsors and contacts
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Source ClinicalTrials.gov