Trial Outcomes & Findings for Transcranial Magnetic Stimulation for "Voices" (NCT NCT00308997)
NCT ID: NCT00308997
Last Updated: 2020-04-02
Results Overview
HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the right superior temporal gyrus. HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement
COMPLETED
PHASE2
85 participants
After 5 sessions of rTMS
2020-04-02
Participant Flow
Participant milestones
| Measure |
Active Arm
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Placebo Arm
sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
29
|
|
Overall Study
COMPLETED
|
55
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Active Arm
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Placebo Arm
sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
|---|---|---|
|
Overall Study
Subject feigned clinical data
|
0
|
1
|
|
Overall Study
Unable to tolerate intervention
|
1
|
0
|
Baseline Characteristics
Transcranial Magnetic Stimulation for "Voices"
Baseline characteristics by cohort
| Measure |
Active Arm
n=55 Participants
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Placebo Arm
n=28 Participants
sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
34.0 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
35.8 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 5 sessions of rTMSPopulation: Subjects who did not complete the intervention were not analyzed
HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the right superior temporal gyrus. HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement
Outcome measures
| Measure |
Active Arm
n=55 Participants
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Placebo Arm
n=28 Participants
sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
|---|---|---|
|
Hallucination Change Score - Right (HCS-right)
|
7.78 units on a scale
Standard Deviation 2.68
|
9.30 units on a scale
Standard Deviation 1.47
|
PRIMARY outcome
Timeframe: After 5 sessions of rTMSPopulation: Subjects who did not complete the intervention were not included in the analysis
HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the left superior temporal gyrus. HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement
Outcome measures
| Measure |
Active Arm
n=55 Participants
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Placebo Arm
n=28 Participants
sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
|---|---|---|
|
Hallucination Change Score - Left (HCS-left)
|
8.65 units on a scale
Standard Deviation 2.74
|
8.50 units on a scale
Standard Deviation 1.59
|
PRIMARY outcome
Timeframe: After 15 sessions of rTMSPopulation: Subjects who did not complete the intervention were excluded from the analysis
HCS score assessed after 15 sessions, 16 minutes per session, delivered to both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation. For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement
Outcome measures
| Measure |
Active Arm
n=55 Participants
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Placebo Arm
n=28 Participants
sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
|---|---|---|
|
Hallucination Change Score (HCS)
|
6.45 units on a scale
Standard Deviation 3.42
|
7.51 units on a scale
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: After 15 sessions of rTMSPopulation: Subjects who did not complete the intervention were excluded from the analysis
AHRS frequency scale score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The hallucination frequency range is from 0-9. The scores reported are difference scores, and an improvement is a higher score. Hallucination frequency is one of the variables incorporated into the AHRS (Auditory Hallucinations Rating Scale). The score is measured as change relative to baseline (i.e., baseline minus endpoint). Larger (positive) scores correspond to greater improvement.
Outcome measures
| Measure |
Active Arm
n=55 Participants
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Placebo Arm
n=28 Participants
sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
|---|---|---|
|
Change in Hallucination Frequency
|
1.31 units on a scale
Standard Deviation 1.57
|
0.30 units on a scale
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: After 15 sessions of rTMSPopulation: Subjects who did not complete the intervention were excluded from the analysis
Total AHRS score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The score range is from 0-42. This is reported as a difference score and a higher score is an improvement. Total AHRS score is measured as change relative baseline (i.e., baseline minus endpoint). Larger (positive) scores correspond to greater improvement.
Outcome measures
| Measure |
Active Arm
n=55 Participants
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Placebo Arm
n=28 Participants
sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
|---|---|---|
|
Change in Total Auditory Hall Rating Scale (AHRS) Score
|
4.48 units on a scale
Standard Deviation 6.90
|
3.0 units on a scale
Standard Deviation 6.21
|
SECONDARY outcome
Timeframe: After 15 sessions of rTMSPopulation: Subjects who did not complete the intervention were excluded from the analysis
CGI score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The range for this score is from 1 to 7. Lower scores correspond to greater improvement
Outcome measures
| Measure |
Active Arm
n=55 Participants
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Placebo Arm
n=28 Participants
sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
|---|---|---|
|
Clinical Global Improvement (CGI)Improvement
|
2.72 units on a scale
Standard Deviation 1.15
|
3.21 units on a scale
Standard Deviation 1.35
|
Adverse Events
Active Arm
Placebo Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Arm
n=55 participants at risk
Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area
Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
Placebo Arm
n=28 participants at risk
sham rTMS to Wernicke's area and a right homologous area
1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.
|
|---|---|---|
|
General disorders
Somatic Discomfort
|
25.5%
14/55 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
14.3%
4/28 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
|
Nervous system disorders
Lightheaded/Dizziness
|
9.1%
5/55 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
0.00%
0/28 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
|
Nervous system disorders
Concentration Problems
|
5.5%
3/55 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
3.6%
1/28 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.5%
3/55 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
0.00%
0/28 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
|
Psychiatric disorders
Worsening Hallucinations/Audible Thoughts
|
9.1%
5/55 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
3.6%
1/28 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
|
Nervous system disorders
Headache
|
21.8%
12/55 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
14.3%
4/28 • Adverse event data was collected throughout the duration of the study, which was approximately 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place