Trial Outcomes & Findings for Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia (NCT NCT01595503)

Results Overview

Hallucination Change Scale (Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, et al. (2005): Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 58:97-104.) Baseline score, by definition: 10 Range: 0 (no hallucinations) to 20 (hallucinations twice as bad as baseline) Thus, a score of less than 10 means that hallucinations were reduced, whereas a score of greater than 10 means that hallucinations were increased.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Two weeks

Results posted on

2021-12-08

Participant Flow

The study was terminated because of the small enrollment (2 or 3 subjects per treatment arm), the data that was examined was pooled for all the subjects. At the time of results reporting it is impossible to disambiguate the two arms. Randomization tables are not available; hence, we cannot report the results by treatment arm.

Participant milestones

Participant milestones
Measure	rTMS With Either fMRI-based Targeting or Landmark Based Targeting. rTMS Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rTMS With fMRI-based Targeting or Landmark Based Targeting n=5 Participants rTMS: Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions.
Age, Continuous	39.8 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks

Population: The two original groups: with fMRI targeted and landmark based were planned to be analyzed separately, the data available at the time of results reporting, is no longer separable. Thus all treated participants are included in a single arm. While this does not allow comparison between the two approaches to rTMS usage, it still allows one to see the impact of using rTMS with one method or the other, albeit still in a tiny sample size.

Hallucination Change Scale (Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, et al. (2005): Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 58:97-104.) Baseline score, by definition: 10 Range: 0 (no hallucinations) to 20 (hallucinations twice as bad as baseline) Thus, a score of less than 10 means that hallucinations were reduced, whereas a score of greater than 10 means that hallucinations were increased.

Outcome measures

Outcome measures
Measure	rTMS n=5 Participants rTMS : Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions.
Change in Severity of Auditory Hallucinations	5.9 score on a scale Standard Deviation 1.7

Adverse Events

rTMS

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

stephan taylor

University of Michigan

Phone: 7349364955

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place