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Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation for "Voices" (NCT NCT00004980)

NCT ID: NCT00004980

Last Updated: 2013-08-07

Results Overview

Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

Results posted on

2013-08-07

Participant Flow

Participant milestones

Participant milestones
Measure
Active Repetitive Transcanial Magnetic Stimulation
Participants received active repetitive transcranial magnetic stimulation (rTMS)
Placebo
Participants received sham stimulation
Overall Study
STARTED
27
23
Overall Study
COMPLETED
25
21
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Active Repetitive Transcanial Magnetic Stimulation
Participants received active repetitive transcranial magnetic stimulation (rTMS)
Placebo
Participants received sham stimulation
Overall Study
Withdrawal by Subject
1
0
Overall Study
memory difficulties
1
1
Overall Study
Physician Decision
0
1

Baseline Characteristics

Repetitive Transcranial Magnetic Stimulation for "Voices"

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active Repetitive Transcanial Magnetic Stimulation
n=27 Participants
Participants received active repetitive transcranial magnetic stimulation (rTMS)
Placebo
n=23 Participants
Participants received sham stimulation
Total
n=50 Participants
Total of all reporting groups
Age Continuous
35.1 Years
STANDARD_DEVIATION 11.9 • n=93 Participants
35.5 Years
STANDARD_DEVIATION 9.5 • n=4 Participants
35.3 Years
STANDARD_DEVIATION 10.8 • n=27 Participants
Sex: Female, Male
Female
9 Participants
n=93 Participants
8 Participants
n=4 Participants
17 Participants
n=27 Participants
Sex: Female, Male
Male
18 Participants
n=93 Participants
15 Participants
n=4 Participants
33 Participants
n=27 Participants
Medication Resistance
Medication Resistant
21 Participants
n=93 Participants
18 Participants
n=4 Participants
39 Participants
n=27 Participants
Medication Resistance
Not Medication Resistant
6 Participants
n=93 Participants
5 Participants
n=4 Participants
11 Participants
n=27 Participants
Total Auditory Hallucination Rate Scale (AHRS) score
25.1 Scores on a scale
STANDARD_DEVIATION 5.0 • n=93 Participants
26.1 Scores on a scale
STANDARD_DEVIATION 5.7 • n=4 Participants
25.6 Scores on a scale
STANDARD_DEVIATION 5.3 • n=27 Participants

PRIMARY outcome

Timeframe: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

Population: Last Observation Carried Forward (LOCF)

Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline

Outcome measures

Outcome measures
Measure
Active Repetitive Transcanial Magnetic Stimulation
n=27 Participants
Participants received active repetitive transcranial magnetic stimulation (rTMS)
Placebo
n=23 Participants
Participants received sham stimulation
Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions
5.85 Units on a scale
Standard Deviation 2.85
8.61 Units on a scale
Standard Deviation 3.80

SECONDARY outcome

Timeframe: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

Population: LOCF

Difference between baseline hallucination frequency and hallucintion frequency at last assessment. Assessed on the basis of a 0-9 scale, with higher scores being more severe.

Outcome measures

Outcome measures
Measure
Active Repetitive Transcanial Magnetic Stimulation
n=27 Participants
Participants received active repetitive transcranial magnetic stimulation (rTMS)
Placebo
n=23 Participants
Participants received sham stimulation
Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions
1.42 Score on a scale
Standard Deviation 1.49
.15 Score on a scale
Standard Deviation 1.14

SECONDARY outcome

Timeframe: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

Scaled from 1-7 as follows: 1=dramatically improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worsened, 6=moderately worsened, 7=dramatically worsened

Outcome measures

Outcome measures
Measure
Active Repetitive Transcanial Magnetic Stimulation
n=26 Participants
Participants received active repetitive transcranial magnetic stimulation (rTMS)
Placebo
n=22 Participants
Participants received sham stimulation
Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions
2.84 Units on a scale
Standard Deviation .845
3.79 Units on a scale
Standard Deviation .882

SECONDARY outcome

Timeframe: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

Population: LOCF

Responder defined as a participant who attains an endpoint hallucination change score (HCS) of 5 or lower after 9 active/shame rTMS sessions. Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline

Outcome measures

Outcome measures
Measure
Active Repetitive Transcanial Magnetic Stimulation
n=27 Participants
Participants received active repetitive transcranial magnetic stimulation (rTMS)
Placebo
n=23 Participants
Participants received sham stimulation
Responder Status
14 Participants
4 Participants

Adverse Events

Active Repetitive Transcanial Magnetic Stimulation

Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Active Repetitive Transcanial Magnetic Stimulation
n=27 participants at risk
Participants received active repetitive transcranial magnetic stimulation (rTMS)
Placebo
n=23 participants at risk
Participants received sham stimulation
Nervous system disorders
Headache
59.3%
16/27 • Adverse event reporting was collected for the duration of the study (41 months)
Adverse events were systematically collected with focused questions each day during the trial
13.0%
3/23 • Adverse event reporting was collected for the duration of the study (41 months)
Adverse events were systematically collected with focused questions each day during the trial

Additional Information

Ralph Hoffman

Yale University School of Medicine

Phone: 203-688-9734

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place