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Individualized Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations
NA trial testing Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia and Related Disorders in 11 participants. Terminated before completion.
| Lead sponsor | Columbia University |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 1 August 2022 |
| Primary completion | 31 March 2023 |
| Estimated completion | 7 April 2023 |
| Sites | 1 location across United States |
Columbia University
Adults 22 to 55, any sex, with Schizophrenia and Related Disorders. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 54 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 22 |
The AHRS is an investigator-administered scale assessing multiple characteristics of auditory verbal hallucinations. The total score ranges from 2 to 41, with higher scores indicating more severe symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 13.8 | ± 8.8 |
The PSYRATS consists of 17 items on delusions and auditory hallucinations subscales, with each item being rated from 0 (absent) to 4 (severe). The score range for the auditory hallucinations subscale is 0-44 with a higher score indicating more severe auditory hallucinations.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 12.8 | ± 14.3 |
The PSYRATS consists of 17 items on delusions and auditory hallucinations, with each item being rated from 0 (absent) to 4 (severe). The score range for the delusion subscale is 0-24 with a higher score indicating more delusion symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 2 | ± 8.7 |
The SAPS includes 34 items that focus on the positive symptoms on schizophrenia. Each item is rated on a severity scale that ranges from 0 (none) to 5 (severe). The hallucination subscale scores range from 0-35 with a higher score indicating more severe hallucinations.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 1.6 | ± 1.3 |
The SAPS includes 34 items that focus on the positive symptoms on schizophrenia. Each item is rated on a severity scale that ranges from 0 (none) to 5 (severe). The delusion subscale has a range from 0-65 with a higher score indicating more severe delusion symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 0.2 | ± 1.5 |
The PANSS rates the presence and severity of positive and negative symptoms, as well as general psychopathology associated with schizophrenia. The general psychopathology subscale is a measure of deficits in cognition with scores ranging from 16-112. Higher scores indicate more severe symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 1.8 | ± 0.8 |
The PANSS rates the presence and severity of positive and negative symptoms, as well as general psychopathology associated with schizophrenia. Positive symptoms defined as a symptom of schizophrenia that represents an excess or distortion of normal function, as distinct from a deficiency in or lack of normal function (compare negative symptom). Positive symptoms include delusions or hallucinations, disorganized behavior, and manifest conceptual disorganization. Positive symptom subscale ranges from 7-49 with a higher score indicating more severe symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 3.2 | ± 4.1 |
The PANSS rates the presence and severity of positive and negative symptoms, as well as general psychopathology associated with schizophrenia. Negative symptoms defined as a deficit in the ability to perform the normal functions of living-for example, logical thinking, self-care, social interaction, and planning, initiating, and carrying out constructive actions-as shown in apathy, blunted affect, emotional withdrawal, poor rapport, and lack of spontaneity. The negative symptoms sub scale scores range from 7-49 with a higher score indicating more severe symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 2.4 | ± 1.1 |
The CAPS is a 32 item scale for measuring perceptual anomalies, that includes subscales for measuring distress, intrusiveness and frequency. A higher score indicates a higher number of perceptual anomalies, total scores range from 0 (low) to 32 (high).
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 3.6 | ± 3.2 |
The CGI-I is a clinician-rated scale to quantify overall clinician impression of improvements in level of illness.The CGI-I is rated on a 7-point scale, to assess illness improvement. CGI-I scores range from 1 (very much improved) through to 7 (very much worse). The scale is used as a safety stop in this study. A worsening in CGI-I score of 2 or greater from baseline for two consecutive days results in withdrawal of the participant from the study.
| Group | Value | 95% CI |
|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 0 |
Time frame: The investigators assessed participants' adverse events on a daily basis throughout the two-week TMS treatment, as well as each time participants underwent study procedures like EEG and MRI over the four-week study duration. The total time period over which adverse event data were collected was 4 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Individualized Magnetic Re… |
|---|---|---|
| Headache | Nervous system disorders | — |
| Dizziness | Investigations | — |
| Facial pain | Nervous system disorders | — |
| Lightheadedness | Nervous system disorders | — |
| Neck discomfort | Nervous system disorders | — |
| Disorientation | Investigations | — |
| Back pain | Nervous system disorders | — |
Data from ClinicalTrials.gov NCT05319080 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial.
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