Trial Outcomes & Findings for Individualized Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations (NCT NCT05319080)
NCT ID: NCT05319080
Last Updated: 2024-04-23
Results Overview
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.
TERMINATED
NA
11 participants
2 weeks.
2024-04-23
Participant Flow
Participant milestones
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
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.
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.
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
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.
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.
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Overall Study
Withdrawal by Subject
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2
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Overall Study
Physician Decision
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4
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Baseline Characteristics
Individualized Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations
Baseline characteristics by cohort
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=11 Participants
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.
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.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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11 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black or African American
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5 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Haitian
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Unknown
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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11 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 2 weeks.Population: Out of the 11 participants, 5 successfully finished all 10 treatment sessions, resulting in a combined total of 50 sessions. Additionally, two participants withdrew from the study early: one managed to complete 1 TMS treatment session, while the other completed 3 treatment sessions.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=11 Participants
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.
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.
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Total Number of rTMS Sessions Completed
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54 sessions
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PRIMARY outcome
Timeframe: 2 weeks.Population: We enrolled 11 participants in total, out of which 5 successfully completed all study procedures. Among the 6 participants who withdrew from the study midway, only 2 managed to complete a few TMS treatment sessions (the other 4 participants dropped out before the TMS treatment procedures began). As a result, we conducted an analysis in the 7 participants that completed at least one session, to assess any adverse events that occurred during the 2-week treatment session.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=7 Participants
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.
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.
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Total Number of Treatment Emergent Adverse Events
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22 events
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SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Scale scores were collected at both baseline and 4 weeks in the 5 participants that completed the study.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=5 Participants
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.
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.
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Change in Auditory Hallucination Rating Scale (AHRS)
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13.8 score on a scale
Standard Deviation 8.8
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SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Scale scores were collected at both baseline and 4 weeks in the 5 participants that completed the study.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=5 Participants
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.
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.
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Change in Psychotic Symptom Rating Scale (PSYRATS)- Auditory Hallucinations
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12.8 score on a scale
Standard Deviation 14.3
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SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Scale scores were collected at both baseline and 4 weeks in the 5 participants that completed the study.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=5 Participants
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.
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.
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Change in Psychotic Symptom Rating Scale (PSYRATS) - Delusion Symptoms
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2 score on a scale
Standard Deviation 8.7
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SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Scale scores were collected at both baseline and 4 weeks in the 5 participants that completed the study.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=5 Participants
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.
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.
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Change in Scale for the Assessment of Positive Symptoms (SAPS)- Hallucinations
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1.6 score on a scale
Standard Deviation 1.3
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SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Scale scores were collected at both baseline and 4 weeks in the 5 participants that completed the study.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=5 Participants
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.
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.
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Change in Scale for the Assessment of Positive Symptoms (SAPS)- Delusions
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0.2 score on a scale
Standard Deviation 1.5
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SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Scale scores were collected at both baseline and 4 weeks in the 5 participants that completed the study.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=5 Participants
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.
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.
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Change in Positive and Negative Syndrome Scale (PANSS)- General Psychopathology
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1.8 score on a scale
Standard Deviation 0.8
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SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Scale scores were collected at both baseline and 4 weeks in the 5 participants that completed the study.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=5 Participants
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.
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.
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Change in Positive and Negative Syndrome Scale (PANSS)- Positive Symptoms
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3.2 score on a scale
Standard Deviation 4.1
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SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Scale scores were collected at both baseline and 4 weeks in the 5 participants that completed the study.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=5 Participants
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.
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.
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Change in Positive and Negative Syndrome Scale (PANSS)- Negative Symptoms
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2.4 score on a scale
Standard Deviation 1.1
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SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Scale scores were collected at both baseline and 4 weeks in the 5 participants that completed the study.
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).
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=5 Participants
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.
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.
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Change in Cardiff Anomalous Perceptions Scale (CAPS)
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3.6 score on a scale
Standard Deviation 3.2
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SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: The investigators enrolled a total of 11 participants. Seven of 11 completed the CGI-I scale at the 2 week timepoint.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=7 Participants
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.
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.
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Number of Participants Withdrawn Resulting From a Change in Clinical Global Impression Improvement (CGI-I) Scale Score
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0 Participants
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SECONDARY outcome
Timeframe: 2 weeksPopulation: The investigators enrolled a total of 11 participants. Seven of 11 completed the CGI-I scale at the 2 week timepoint.
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.
Outcome measures
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=7 Participants
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.
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.
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Number of Participants Withdrawn Resulting From the Clinical Global Impression Severity (CGI-S) Scale Score
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0 Participants
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Adverse Events
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Individualized Magnetic Resonance Imaging (MRI) Guided rTMS
n=11 participants at risk
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.
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.
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Nervous system disorders
Headache
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18.2%
2/11 • 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.
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Nervous system disorders
Facial pain
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9.1%
1/11 • 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.
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Nervous system disorders
Lightheadedness
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9.1%
1/11 • 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.
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Nervous system disorders
Neck discomfort
|
9.1%
1/11 • 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.
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Investigations
Dizziness
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18.2%
2/11 • 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.
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Investigations
Disorientation
|
9.1%
1/11 • 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.
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|
Nervous system disorders
Back pain
|
9.1%
1/11 • 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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place