Boost rTMS for Auditory Verbal Hallucinations

NCT03544333 | Terminated Results FDA Device

• 1 other identifier: 18-0024
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, placebo controlled, double-blind clinical trial. The investigators aim to examine the safety and efficacy of repeated transcranial magnetic stimulation (rTMS) for the treatment of auditory verbal hallucinations (AVH) in patients with schizophrenia who are not taking antipsychotic medication. The investigators employ a novel, accelerated protocol with only four sessions of low-frequency rTMS in one day. The effects of this accelerated protocol will be compared to the sham stimulation. Additionally, the investigators will examine the effects of rTMS on a neurophysiological level by evaluating mechanism of action in the temporo-parietal lobe by means of functional magnetic resonance imaging.

Conditions

Schizophrenia; Auditory Hallucination

Keywords

transcranial magnetic stimulation (TMS); brain stimulation; medication-free

Outcome Measures

Primary Outcomes (1)

• Efficacy of Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations Assessed With the Hallucination Change Scale

  Examine change in AVH severity, measured with the Hallucination Change Scale, due to low-frequency rTMS. The Hallucination Change Scale is a self-rating assesses severity of hallucinations. It is anchored at baseline using the patient's description of AVH for the previous 24-hours which is assigned a score of 10. The subsequent assessments are in relation to the baseline where a reduction of AVH relates to a value \< 10 (best being a value of 0) and a worsening of AVH relates to a value \> 10 (twice as severe as baseline being a value of 20).

  Four timepoints of the Hallucination Change Scale (after every TMS session). Here, score after final session is reported.

Study Arms (2)

real transcranial magnetic stimulation

EXPERIMENTAL

In the treatment arm, patients will receive 1Hz of repetitive transcranial magnetic stimulation (rTMS) over the left Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al.,1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.

Device: transcranial magnetic stimulation

sham transcranial magnetic stimulation

PLACEBO COMPARATOR

In the comparator arm, patients will receive no stimulation. The TMS coil adjusted to the patients head will not be plugged into the TMS machine and can thus not have an effect on the brain. Yet, patients will hear the same noises from a coil that is plugged in, see the TMS machine running, and area Spt localized via baseline structural imaging and our Localite TMS navigation system.

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.

real transcranial magnetic stimulation; sham transcranial magnetic stimulation

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 to 65
• Diagnosed with Diagnostic and Statistical Manual (DSM) V diagnosis of schizophrenia (295.90), schizoaffective disorder (295.70), or brief psychotic disorder (298.80), prone to AVH in the acute phases of the disorder
• Willing to adhere to the rTMS regimen
• No antipsychotic medication in the last two weeks prior to the start of the study as well as no antipsychotic medication during participation in the study
• Agreement to adhere to Lifestyle Considerations throughout study duration

You may not qualify if:

• Current use of antipsychotic medication within the last 2 weeks
• Electroconvulsive therapy or rTMS within three months (see the TMS screening questionnaire)
• History of seizures
• Presence of implanted electronic device or metal implant in the head and neck region (DBS, cochlear implant, etc.)
• Pregnancy, as assessed with a pregnancy test prior to every MRI measurement, or lactation
• Any active general medical condition or central nervous system disease which can affect cognition or response to treatment
• Treatment with another investigational drug or other intervention within 2 weeks
• Current diagnosis of delirium, dementia, or amnestic amnesiac disorder; Diagnosis of mental retardation; Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week as indicated by self-report.
• Patients who are cognitively impaired and are thus not able to give informed consent

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

The Zucker Hillside Hospital, Northwell Health

Manhasset, New York, 11004, United States

Location

MeSH Terms

Conditions

Schizophrenia; Hallucinations

Interventions

Transcranial Magnetic Stimulation

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; Therapeutics

Results Point of Contact

• Title: Stephanie Homan, PhD
• Organization: University Hospital of Psychiatry Zurich, Switzerland

stephanie.homan@bli.uzh.ch

0041 44 384

Study Officials

• Philipp Homan, MD PhD

  Zucker Hillside Hospital, New York City, USA.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Investigator

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: June 1, 2018
• Study Start: April 16, 2018
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: May 5, 2021
• Results First Posted: May 5, 2021

Record last verified: 2021-04

Locations

US (1)