Individualized Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations

NCT05319080 | Terminated Results FDA Device

• 2 other identifiers: 8116K23MH119318
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The Repetitive Transcranial Magnetic Stimulation (rTMS) is a type of brain stimulation that uses a magnet to change activity in the brain. rTMS uses magnetic pulses to induce an electrical current in the brain to alter brain activity and function in specific areas. For example, stimulating the part of the brain controlling movement will cause parts of the foot or leg to twitch. TMS is proposed as a novel treatment for people with schizophrenia. The investigators want to see if low frequency rTMS can lessen some of the symptoms of schizophrenia, specifically auditory verbal hallucinations. Auditory verbal hallucinations describe the experience of hearing voices that are not really there.

Conditions

Schizophrenia and Related Disorders

Keywords

Hallucinations; Auditory Verbal Hallucinations

Outcome Measures

Primary Outcomes (2)

• Total Number of rTMS Sessions Completed

  The total number of rTMS sessions completed. A session is defined as 20 minutes of rTMS. The outcome measure data comprises the cumulative count of all completed TMS sessions.

  2 weeks.

• Total Number of Treatment Emergent Adverse Events

  The total number of treatment emergent adverse events. An emergent adverse event is defined as any rTMS risk induced incident in research such as headache and seizure.

  2 weeks.

Secondary Outcomes (11)

• Change in Auditory Hallucination Rating Scale (AHRS)

  Baseline and 4 weeks

• Change in Psychotic Symptom Rating Scale (PSYRATS)- Auditory Hallucinations

  Baseline and 4 weeks

• Change in Psychotic Symptom Rating Scale (PSYRATS) - Delusion Symptoms

  Baseline and 4 weeks

• Change in Scale for the Assessment of Positive Symptoms (SAPS)- Hallucinations

  Baseline and 4 weeks

• Change in Scale for the Assessment of Positive Symptoms (SAPS)- Delusions

  Baseline and 4 weeks

Study Arms (1)

Individualized magnetic resonance imaging (MRI) guided rTMS

EXPERIMENTAL

Participants will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will receive a 20-min once-daily rTMS sessions over a period of 2 weeks (weekends off), and therefore accrue a total of 10 rTMS stimulation sessions. The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

During the rTMS session, an electromagnetic coil is placed against the subjects scalp on the left side of the head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception.

Individualized magnetic resonance imaging (MRI) guided rTMS

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder
• Capacity and willingness to provide informed consent
• Mean Auditory Hallucination Rating Scale (AHRS) item score of greater or equal to 2
• If female and not infertile, must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment, an intrauterine device (IUD) which was implanted at least 2 months prior to screening, or "double-barrier" contraception. Women of child bearing potential must have a negative pregnancy test at screening
• Right handed
• Normal hearing
• Taking an antipsychotic medication at a stable dose for at least 4 weeks. All oral and depot antipsychotics are allowable.

You may not qualify if:

• Substance use disorder (excluding nicotine) within last 90 days, or positive toxicology screen for any substance of abuse
• Pregnancy
• Participation in study of investigational medication/device within 4 weeks
• History of seizure, epilepsy and neurologic conditions with structural cerebral damage, including stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers, dementia, developmental disability, cerebrovascular disease, increased intracranial pressure, or central nervous system (CNS) tumors, brain surgery, head injury with loss of consciousness \>1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesion
• Subjects with devices that may be affected by TMS (pacemaker, cardioverter defibrillator, medication pump, intracardiac line, cochlear implant, implanted brain stimulator/neurostimulator)
• Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator
• Frequent and persistent migraines
• Clinically significant skin disease
• Presence of unstable medical disorders, including those that are previously undiagnosed, untreated, inadequately treated, or active to an extent which might make participation hazardous. For example, hypertension, previous stroke, brain lesions, or heart disease
• History of prior clinically significant, adverse response to neurostimulation
• Current treatment with ototoxic medications (amino-glycosides, cisplatin)
• MRI incompatible implants
• Claustrophobia

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, 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

Limitations and Caveats

The study ended prematurely, resulting in a sample size that did not meet our expectations.

Results Point of Contact

• Title: Michael Avissar
• Organization: New York State Psychiatric Institute

MichaelAvissarMDPhD@gmail.com

(646) 774-5431

Study Officials

• Michael Avissar, MD, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: This is an open-label study for participants with a diagnosis of either schizophrenia or schizoaffective disorder with persistent auditory verbal hallucinations (AVH) that are eligible to have repetitive transcranial magnetic stimulation (rTMS) targeting the left temporoparietal junction (TPJ).

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 8, 2022
• Study Start: August 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: April 7, 2023
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)