Trial Outcomes & Findings for An Extension Protocol for Patients Who Previously Completed the TMS Pilot Study (NCT NCT05526833)
NCT ID: NCT05526833
Last Updated: 2024-02-16
Results Overview
The total number of rTMS sessions completed for non responders and partial responders. A session is defined as 20 minutes of rTMS.
TERMINATED
NA
3 participants
2 weeks.
2024-02-16
Participant Flow
Participant milestones
| Measure |
Non-responders Undergo rTMS of the Right Superior Temporal Sulcus (STS)
Non-responders to protocol #8116 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 be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the right superior temporal sulcus (STS). 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 on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception.
|
Partial Responders Undergo rTMS of the Left Temporo-parietal Junction (TPJ)
Partial responders to protocol #8116 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 be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the original left temporo-parietal junction (TPJ) target. 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 on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception.
|
Complete Responders Undergo Four Follow-up Clinical Assessments
Complete responders to protocol #8116 will be offered followup clinical assessments at 1, 2, 4, and 8 weeks to assess sustainability of their response.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
Baseline characteristics by cohort
| Measure |
Non-responders Undergo rTMS of the Right Superior Temporal Sulcus (STS)
n=1 Participants
Non-responders to protocol #8116 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 be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the right superior temporal sulcus (STS). 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 on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception.
|
Partial Responders Undergo rTMS of the Left Temporo-parietal Junction (TPJ)
n=1 Participants
Partial responders to protocol #8116 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 be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the original left temporo-parietal junction (TPJ) target. 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 on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception.
|
Complete Responders Undergo Four Follow-up Clinical Assessments
n=1 Participants
Complete responders to protocol #8116 will be offered followup clinical assessments at 1, 2, 4, and 8 weeks to assess sustainability of their response.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Age, Categorical
>=65 years
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Race (NIH/OMB)
White
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
1 participants
n=1 Participants
|
1 participants
n=1 Participants
|
3 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 2 weeks.Population: Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants.
The total number of rTMS sessions completed for non responders and partial responders. A session is defined as 20 minutes of rTMS.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 weeksPopulation: Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants.
The total number of follow-up clinical assessments completed for complete responders. A clinical assessment refers to answering questions about psychiatric symptoms to assess the sustainability of the patient's improvement from the previous study.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 weeks.Population: Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants.
The total number of treatment emergent adverse events for non responders and partial responders. An emergent adverse event is defined as any rTMS risk induced incident in research such as headache and seizure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4/8 weeks.Population: Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants.
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
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4/8 weeks.Population: Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants.
The PSYRATS consists of 17 items on delusions and auditory hallucinations, with each item being rated from 0 (absent) to 4 (severe). The total score ranges from 0 to 68, with higher scores indicating more severe symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4/8 weeks.Population: Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants.
The SAPS includes 34 items that focus on the positive symptoms on schizophrenia. Each item is rated from o to 5 (range=0-170). Higher scores indicate more severe symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4/8 weeks.Population: Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants.
The PANSS rates the presence and severity of positive and negative symptoms, as well as general psychopathology associated with schizophrenia. Each item is rated from 1 to 7 (range=30-210). Higher scores indicate more severe symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4/8 weeks.Population: Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants.
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, scores range from 0 (low) to 32 (high).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants.
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, to assess illness severity. CGI-S scores range from 1 (normal, not ill) through to 7 (among the most severely ill patients).
Outcome measures
Outcome data not reported
Adverse Events
Non-responders Undergo rTMS of the Right Superior Temporal Sulcus (STS)
Partial Responders Undergo rTMS of the Left Temporo-parietal Junction (TPJ)
Complete Responders Undergo Four Follow-up Clinical Assessments
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place