Status:
TERMINATED
Individualized Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia and Related Disorders
Eligibility:
All Genders
22-55 years
Phase:
NA
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 ...
Detailed Description
The large majority of patients with schizophrenia (Sz) experience auditory verbal hallucinations (AVH) as a core feature of their disorder. Treatment-resistant auditory verbal hallucinations (AVH) aff...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05319080
Start Date
August 1 2022
End Date
April 7 2023
Last Update
April 23 2024
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032