Trial Outcomes & Findings for Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia (NCT NCT05643196)
NCT ID: NCT05643196
Last Updated: 2025-05-30
Results Overview
Change in GPi functional connectivity measured via functional MRI (fMRI) captured pre-sonication and 10 minutes post-sonication during the PLIFUS intervention visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Immediately pre-sonication and 10 minutes post-sonication at Intervention Visit 1 (Day 0) and Intervention Visit 2 (Day 7)
Results posted on
2025-05-30
Participant Flow
Participant milestones
| Measure |
Pulsed Low-Intensity Focused Ultrasound (PLIFUS), Then Sham
Participants will receive PLIFUS sonication on the first intervention visit, then sham sonication on the second intervention visit. Visits will be separated by 1 week. Sonication at both visits will be preceded and followed by fMRI and an exit medical examination. Sonication will be delivered in a pulse pattern over 10 minutes.
PLIFUS: The Sonicator-1000 system will non-invasively deliver ultrasound sonications transcranially that selectively target specific areas of the brain using a neuronavigation system and the participant's MRI brain scan. The sonication parameters follow FDA and Electrotechnical Technical Commission regulation standards for diagnostic and therapeutic ultrasound.
Sham PLIFUS: Sham PLIFUS treatment delivers noise and patient experience that is identical to PLIFUS with Sonicator-1000 system.
MRI: A total of 5 MRIs will be performed using a Siemens 3T Prisma; one prior to the intervention visit, and one preceding and one immediately after each of the two sonication/sham visits.
|
Sham, Then Pulsed Low-Intensity Focused Ultrasound (PLIFUS)
Participants will receive sham sonication on the first intervention visit, then PLIFUS sonication on the second intervention visit. Visits will be separated by 1 week. Sonication at both visits will be preceded and followed by fMRI and an exit medical examination. Sonication will be delivered in a pulse pattern over 10 minutes.
PLIFUS: The Sonicator-1000 system will non-invasively deliver ultrasound sonications transcranially that selectively target specific areas of the brain using a neuronavigation system and the participant's MRI brain scan. The sonication parameters follow FDA and Electrotechnical Technical Commission regulation standards for diagnostic and therapeutic ultrasound.
Sham PLIFUS: Sham PLIFUS treatment delivers noise and patient experience that is identical to PLIFUS with Sonicator-1000 system.
MRI: A total of 5 MRIs will be performed using a Siemens 3T Prisma; one prior to the intervention visit, and one preceding and one immediately after each of the two sonication/sham visits.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
Participants Started Treatment Period 1 (PLIFUS for Arm 1, Sharm for Arm 2)
|
5
|
5
|
|
Overall Study
Participants Completed Treatment Period 1 (PLIFUS for Arm 1, Sharm for Arm 2)
|
5
|
5
|
|
Overall Study
Participants Started Treatment Period 2 (Sham for Arm 1, PLIFUS for Arm 2)
|
5
|
5
|
|
Overall Study
Participants Completed Treatment Period 2 (Sham for Arm 1, PLIFUS for Arm 2)
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia
Baseline characteristics by cohort
| Measure |
Pulsed Low-Intensity Focused Ultrasound (PLIFUS), Then Sham
n=5 Participants
Participants will receive PLIFUS sonication on the first intervention visit, then sham sonication on the second intervention visit. Visits will be separated by 1 week. Sonication at both visits will be preceded and followed by fMRI and an exit medical examination. Sonication will be delivered in a pulse pattern over 10 minutes.
PLIFUS: The Sonicator-1000 system will non-invasively deliver ultrasound sonications transcranially that selectively target specific areas of the brain using a neuronavigation system and the participant's MRI brain scan. The sonication parameters follow FDA and Electrotechnical Technical Commission regulation standards for diagnostic and therapeutic ultrasound.
Sham PLIFUS: Sham PLIFUS treatment delivers noise and patient experience that is identical to PLIFUS with Sonicator-1000 system.
MRI: A total of 5 MRIs will be performed using a Siemens 3T Prisma; one prior to the intervention visit, and one preceding and one immediately after each of the two sonication/sham visits.
|
Sham, Then Pulsed Low-Intensity Focused Ultrasound (PLIFUS)
n=5 Participants
Participants will receive sham sonication on the first intervention visit, then PLIFUS sonication on the second intervention visit. Visits will be separated by 1 week. Sonication at both visits will be preceded and followed by fMRI and an exit medical examination. Sonication will be delivered in a pulse pattern over 10 minutes.
PLIFUS: The Sonicator-1000 system will non-invasively deliver ultrasound sonications transcranially that selectively target specific areas of the brain using a neuronavigation system and the participant's MRI brain scan. The sonication parameters follow FDA and Electrotechnical Technical Commission regulation standards for diagnostic and therapeutic ultrasound.
Sham PLIFUS: Sham PLIFUS treatment delivers noise and patient experience that is identical to PLIFUS with Sonicator-1000 system.
MRI: A total of 5 MRIs will be performed using a Siemens 3T Prisma; one prior to the intervention visit, and one preceding and one immediately after each of the two sonication/sham visits.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 6.67 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately pre-sonication and 10 minutes post-sonication at Intervention Visit 1 (Day 0) and Intervention Visit 2 (Day 7)Population: No participants were analyzed for this measure/no outcome measure data collected. The reason why this outcome did not have data collected was because there was a software issue with the scanner which made the data not analyzable. No data were collected, nor will any data be collected in relation to this outcome measure.
Change in GPi functional connectivity measured via functional MRI (fMRI) captured pre-sonication and 10 minutes post-sonication during the PLIFUS intervention visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Final Study Visit (Day 14-16)A 7-item scale developed to measure specific characteristics of auditory hallucinations (frequency, reality, loudness, number of voices, length, attentional salience, distress level). Each item is rated on a separate Likert scale. The total score, ranging from 0 to 44, indicates the overall severity of the hallucinations, with higher scores suggesting more severe symptoms.
Outcome measures
| Measure |
PLIFUS
n=10 Participants
PLIFUS: The Sonicator-1000 system will non-invasively deliver ultrasound sonications transcranially that selectively target specific areas of the brain using a neuronavigation system and the participant's MRI brain scan. The sonication parameters follow FDA and Electrotechnical Technical Commission regulation standards for diagnostic and therapeutic ultrasound.
|
Sham
n=10 Participants
Sham PLIFUS: Sham PLIFUS treatment delivers noise and patient experience that is identical to PLIFUS with Sonicator-1000 system.
|
|---|---|---|
|
Change in Auditory Hallucinations Rating Scale (AHRS) Score From Baseline
|
-1.4 score on a scale
Standard Deviation 2.4
|
-1 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline, Final Study Visit (Day 14-16)A 4-item scale (conviction, distress, preoccupation, disruption) used to assess moment-to-moment experience and detect more rapid changes of delusions. Participants are asked to rate the same delusional belief at the moment on a 7-point Likert scale (1 (not at all) to 7 (very much)). The total score is the sum of responses ranging from 1-28; higher scores indicate more severe symptoms.
Outcome measures
| Measure |
PLIFUS
n=10 Participants
PLIFUS: The Sonicator-1000 system will non-invasively deliver ultrasound sonications transcranially that selectively target specific areas of the brain using a neuronavigation system and the participant's MRI brain scan. The sonication parameters follow FDA and Electrotechnical Technical Commission regulation standards for diagnostic and therapeutic ultrasound.
|
Sham
n=10 Participants
Sham PLIFUS: Sham PLIFUS treatment delivers noise and patient experience that is identical to PLIFUS with Sonicator-1000 system.
|
|---|---|---|
|
Change in Delusions Experience Sampling Assessment (DESA) Score From Baseline
|
-1 score on a scale
Standard Deviation 3.4
|
0.3 score on a scale
Standard Deviation 2.9
|
Adverse Events
PLIFUS
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PLIFUS
n=10 participants at risk
PLIFUS: The Sonicator-1000 system will non-invasively deliver ultrasound sonications transcranially that selectively target specific areas of the brain using a neuronavigation system and the participant's MRI brain scan. The sonication parameters follow FDA and Electrotechnical Technical Commission regulation standards for diagnostic and therapeutic ultrasound.
|
Sham
n=10 participants at risk
Sham PLIFUS: Sham PLIFUS treatment delivers noise and patient experience that is identical to PLIFUS with Sonicator-1000 system.
|
|---|---|---|
|
Nervous system disorders
Abnormal muscle movement
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Psychiatric disorders
Alcohol craving
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Psychiatric disorders
Anxiety/worry
|
20.0%
2/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Gastrointestinal disorders
Appetite increase
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Nervous system disorders
Ataxia/impaired coordination
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Psychiatric disorders
Delusion
|
20.0%
2/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
20.0%
2/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Psychiatric disorders
Derealization
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Nervous system disorders
Dizziness/faintness
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Psychiatric disorders
Excitement/nervousness
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
General disorders
Fatigue/weakness
|
30.0%
3/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Psychiatric disorders
Hallucinations
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
20.0%
2/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
20.0%
2/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Nervous system disorders
Insomnia
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
20.0%
2/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Nervous system disorders
MoCA Total Score Decrease
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Psychiatric disorders
Mood deterioration
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
20.0%
2/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Nervous system disorders
Sedation/drowsiness
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
20.0%
2/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Nervous system disorders
Sensory perception abnormality
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Gastrointestinal disorders
Stomach/abdominal discomfortg
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Cardiac disorders
Tachycardia/palpitations
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
|
Ear and labyrinth disorders
Tinnitus/difficulty hearing
|
10.0%
1/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
0.00%
0/10 • AE data was collected for all events with start dates occurring any time after informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) + addendum to the SAFTEE used to assess the following side effects that have been reported in other human subject ultrasound studies: mood deterioration, scalp heating, anxiety, neck pain, and pruritis. Schedule: Pre/post-PLIFUS/sham at Intervention Visit 1 (Day 0); Intervention Visit 1B (Day 1-2); Pre/post-PLIFUS/sham at Intervention Visit 2 (Day 6-8); Intervention Visit 2B (Day 7-9); Final Study Visit (Day 14-16)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place