Trial Outcomes & Findings for Boost rTMS for Auditory Verbal Hallucinations (NCT NCT03544333)
NCT ID: NCT03544333
Last Updated: 2021-05-05
Results Overview
Examine change in AVH severity, measured with the Hallucination Change Scale, due to low-frequency rTMS. The Hallucination Change Scale is a self-rating assesses severity of hallucinations. It is anchored at baseline using the patient's description of AVH for the previous 24-hours which is assigned a score of 10. The subsequent assessments are in relation to the baseline where a reduction of AVH relates to a value \< 10 (best being a value of 0) and a worsening of AVH relates to a value \> 10 (twice as severe as baseline being a value of 20).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Four timepoints of the Hallucination Change Scale (after every TMS session). Here, score after final session is reported.
Results posted on
2021-05-05
Participant Flow
Participant milestones
| Measure |
Real Transcranial Magnetic Stimulation
In the treatment arm, patients will receive 1Hz of repetitive transcranial magnetic stimulation (rTMS) over the left Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al.,1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
transcranial magnetic stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
|
Sham Transcranial Magnetic Stimulation
In the comparator arm, patients will receive no stimulation. The TMS coil adjusted to the patients head will not be plugged into the TMS machine and can thus not have an effect on the brain. Yet, patients will hear the same noises from a coil that is plugged in, see the TMS machine running, and area Spt localized via baseline structural imaging and our Localite TMS navigation system.
transcranial magnetic stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Real Transcranial Magnetic Stimulation
In the treatment arm, patients will receive 1Hz of repetitive transcranial magnetic stimulation (rTMS) over the left Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al.,1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
transcranial magnetic stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
|
Sham Transcranial Magnetic Stimulation
In the comparator arm, patients will receive no stimulation. The TMS coil adjusted to the patients head will not be plugged into the TMS machine and can thus not have an effect on the brain. Yet, patients will hear the same noises from a coil that is plugged in, see the TMS machine running, and area Spt localized via baseline structural imaging and our Localite TMS navigation system.
transcranial magnetic stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Pat. did not finish baseline assessment.
Baseline characteristics by cohort
| Measure |
Real Transcranial Magnetic Stimulation
n=2 Participants
In the treatment arm, patients will receive 1Hz of repetitive transcranial magnetic stimulation (rTMS) over the left Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al.,1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
Transcranial magnetic stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
|
Sham Transcranial Magnetic Stimulation
n=2 Participants
In the comparator arm, patients will receive no stimulation. The TMS coil adjusted to the patients head will not be plugged into the TMS machine and can thus not have an effect on the brain. Yet, patients will hear the same noises from a coil that is plugged in, see the TMS machine running, and area Spt localized via baseline structural imaging and our Localite TMS navigation system.
Transcranial magnetic stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.67 years
STANDARD_DEVIATION 5.98 • n=2 Participants
|
27.02 years
STANDARD_DEVIATION 3.75 • n=2 Participants
|
29.84 years
STANDARD_DEVIATION 5.22 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
2 participants
n=2 Participants
|
4 participants
n=4 Participants
|
|
BPRS Total Score
|
36 units on a scale
n=1 Participants • Pat. did not finish baseline assessment.
|
38 units on a scale
n=2 Participants • Pat. did not finish baseline assessment.
|
37 units on a scale
n=3 Participants • Pat. did not finish baseline assessment.
|
|
GAS
|
75 units on a scale
STANDARD_DEVIATION NA • n=1 Participants • Patient was not available for assessment.
|
30 units on a scale
STANDARD_DEVIATION 7.07 • n=2 Participants • Patient was not available for assessment.
|
52.5 units on a scale
STANDARD_DEVIATION NA • n=3 Participants • Patient was not available for assessment.
|
|
Hallucination Change Score
|
7.5 units on a scale
n=2 Participants
|
7.5 units on a scale
n=2 Participants
|
7.5 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: Four timepoints of the Hallucination Change Scale (after every TMS session). Here, score after final session is reported.Population: Pat. lost for followup.
Examine change in AVH severity, measured with the Hallucination Change Scale, due to low-frequency rTMS. The Hallucination Change Scale is a self-rating assesses severity of hallucinations. It is anchored at baseline using the patient's description of AVH for the previous 24-hours which is assigned a score of 10. The subsequent assessments are in relation to the baseline where a reduction of AVH relates to a value \< 10 (best being a value of 0) and a worsening of AVH relates to a value \> 10 (twice as severe as baseline being a value of 20).
Outcome measures
| Measure |
Real Transcranial Magnetic Stimulation
n=2 Participants
In the treatment arm, patients will receive 1Hz of repetitive transcranial magnetic stimulation (rTMS) over the left Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al.,1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
TMS: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
|
Sham Transcranial Magnetic Stimulation
n=2 Participants
In the comparator arm, patients will receive no stimulation. The TMS coil adjusted to the patients head will not be plugged into the TMS machine and can thus not have an effect on the brain. Yet, patients will hear the same noises from a coil that is plugged in, see the TMS machine running, and area Spt localized via baseline structural imaging and our Localite TMS navigation system.
sham stimulation: We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
|
|---|---|---|
|
Efficacy of Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations Assessed With the Hallucination Change Scale
|
15 score on a scale
Interval 15.0 to 15.0
|
7.5 score on a scale
Interval 5.0 to 10.0
|
Adverse Events
Real TMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham TMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stephanie Homan, PhD
University Hospital of Psychiatry Zurich, Switzerland
Phone: 0041 44 384
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place