An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Schizophrenia and Related Disorders, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 22 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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.
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) affect a third of patients with schizophrenia and can cause increased aggression, distress, suicide, and social dysfunction. The current standard of care is antipsychotic medication which can cause metabolic syndrome, sedation, orthostatic hypotension, extrapyramidal symptoms, and tardive dyskinesia among other adverse effects. Transcranial magnetic stimulation (TMS) emits a rapidly changing magnetic field over the scalp which induces current flow in underling brain tissue, either enhancing or disrupting function depending on the frequency of stimulation. It is generally well tolerated and repetitive TMS (rTMS) is currently FDA approved for treatment of depression. rTMS carries potential as an alternative treatment for schizophrenia patients with AVH who either do not respond to or do not tolerate medication. Inhibitory (1-Hz) standard TMS approaches, which use scalp-based targeting of speech perception areas such as left temporoparietal junction (TPJ) have yielded mixed results in reducing AVH, possibly due to variability of underlying brain anatomy between individual subjects. The influence of anatomical variability could be eliminated by individually positioning the TMS coil according to each patient's structural brain MRI. The proposed pilot project will investigate the clinical efficacy of open-label individualized MRI-guided TMS applied to the left TPJ in ten patients with schizophrenia or schizoaffective disorder. If the results of the pilot study show promising reductions in AVH, it will set up the foundation for a larger sham-controlled clinical trial.
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This study's enrollment of 11 is below the median of 50 across 112 interventional studies indexed under Hallucinations.
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Exclusion Criteria:
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)
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.
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.
Time frame: 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.
Time frame: 2 weeks.
Change in Auditory Hallucination Rating Scale (AHRS)
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.
Time frame: Baseline and 4 weeks
Change in Psychotic Symptom Rating Scale (PSYRATS)- Auditory Hallucinations
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.
Time frame: Baseline and 4 weeks
Change in Psychotic Symptom Rating Scale (PSYRATS) - Delusion Symptoms
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.
Time frame: Baseline and 4 weeks
Change in Scale for the Assessment of Positive Symptoms (SAPS)- Hallucinations
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.
Time frame: Baseline and 4 weeks
Change in Scale for the Assessment of Positive Symptoms (SAPS)- Delusions
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.
Time frame: Baseline and 4 weeks
Change in Positive and Negative Syndrome Scale (PANSS)- General Psychopathology
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.
Time frame: Baseline and 4 weeks
Change in Positive and Negative Syndrome Scale (PANSS)- Positive Symptoms
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.
Time frame: Baseline and 4 weeks
Change in Positive and Negative Syndrome Scale (PANSS)- Negative Symptoms
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.
Time frame: Baseline and 4 weeks
Change in Cardiff Anomalous Perceptions Scale (CAPS)
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).
Time frame: Baseline and 4 weeks
Number of Participants Withdrawn Resulting From a Change in Clinical Global Impression Improvement (CGI-I) Scale Score
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.
Time frame: Baseline and 2 weeks
Number of Participants Withdrawn Resulting From the Clinical Global Impression Severity (CGI-S) Scale Score
The CGI-S is a clinician-rated scale to quantify overall clinician impression of illness severity. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The scale is used as a safety stop in this study. A score of 6 or 7 at the two week timepoint results in withdrawal of the participant from the study.
Time frame: 2 weeks
| Milestone | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Started | 11 |
| Completed | 5 |
| Not completed | 6 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Physician decision | 4 |
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.
| sessions | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Total Number of rTMS Sessions Completed | 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.
| events | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Total Number of Treatment Emergent Adverse Events | 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.
| score on a scale | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Change in Auditory Hallucination Rating Scale (AHRS) | 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.
| score on a scale | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Change in Psychotic Symptom Rating Scale (PSYRATS)- Auditory Hallucinations | 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.
| score on a scale | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Change in Psychotic Symptom Rating Scale (PSYRATS) - Delusion Symptoms | 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.
| score on a scale | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Change in Scale for the Assessment of Positive Symptoms (SAPS)- Hallucinations | 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.
| score on a scale | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Change in Scale for the Assessment of Positive Symptoms (SAPS)- Delusions | 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.
| score on a scale | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS)- General Psychopathology | 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.
| score on a scale | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS)- Positive Symptoms | 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.
| score on a scale | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS)- Negative Symptoms | 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).
| score on a scale | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Change in Cardiff Anomalous Perceptions Scale (CAPS) | 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.
| Participants | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Number of Participants Withdrawn Resulting From a Change in Clinical Global Impression Improvement (CGI-I) Scale Score | 0 |
The CGI-S is a clinician-rated scale to quantify overall clinician impression of illness severity. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The scale is used as a safety stop in this study. A score of 6 or 7 at the two week timepoint results in withdrawal of the participant from the study.
| Participants | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Number of Participants Withdrawn Resulting From the Clinical Global Impression Severity (CGI-S) Scale Score | 0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 0/11 (0%) | 0/11 (0%) | 4/11 (36.4%) |
| Event | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| HeadacheNervous system disorders | 2/11 |
| DizzinessInvestigations | 2/11 |
| Facial painNervous system disorders | 1/11 |
| LightheadednessNervous system disorders | 1/11 |
| Neck discomfortNervous system disorders | 1/11 |
| DisorientationInvestigations | 1/11 |
| Back painNervous system disorders | 1/11 |
| Age, Categorical(Participants) | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Female | 4 |
| Male | 7 |
| Race/Ethnicity, Customized(Participants) | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Black or African American | 5 |
| White | 2 |
| Asian | 1 |
| Haitian | 1 |
| Hispanic | 1 |
| Unknown | 1 |
| Region of Enrollment(participants) | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| United States | 11 |
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