https://www.clinicaltrials.gov/ct2/show/results/NCT00004980?cond=hearing+voices&draw=2&rank=8

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Trial record 8 of 10 for:    hearing voices

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Repetitive Transcranial Magnetic Stimulation for “Voices“

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

View this study on Beta.ClinicalTrials.gov

Sponsor:

Yale University 

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Yale University

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Participant Flow 

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Arm/Group Title	Active Repetitive Transcanial Magnetic Stimulation	Placebo
Arm/Group Description	Participants received active repetitive transcranial magnetic stimulation (rTMS)	Participants received sham stimulation
Period Title: Overall Study
Started	27	23
Completed	25	21
Not Completed	2	2
Reason Not Completed
Withdrawal by Subject	1	0
memory difficulties	1	1
Physician Decision	0	1

Baseline Characteristics 

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Arm/Group Title		Active Repetitive Transcanial Magnetic Stimulation	Placebo	Total
Arm/Group Description		Participants received active repetitive transcranial magnetic stimulation (rTMS)	Participants received sham stimulation	Total of all reporting groups
Overall Number of Baseline Participants		27	23	50
Baseline Analysis Population Description		[Not Specified]
Age Continuous   Mean (Standard Deviation)Unit of measure:  Years
	Number Analyzed	27 participants	23 participants	50 participants
		35.1  (11.9)	35.5  (9.5)	35.3  (10.8)
Sex: Female, Male   Measure Type: Count of ParticipantsUnit of measure:  Participants
	Number Analyzed	27 participants	23 participants	50 participants
	Female	9  33.3%	8  34.8%	17  34.0%
	Male	18  66.7%	15  65.2%	33  66.0%
Medication Resistance   [1] Measure Type: NumberUnit of measure:  Participants	Number Analyzed	27 participants	23 participants	50 participants
Medication Resistant		21	18	39
Not Medication Resistant		6	5	11
		[1] Measure Description: Number of participants who were medication resistant
Total Auditory Hallucination Rate Scale (AHRS) score   [1] Mean (Standard Deviation)Unit of measure:  Scores on a scale
	Number Analyzed	27 participants	23 participants	50 participants
		25.1  (5.0)	26.1  (5.7)	25.6  (5.3)
		[1] Measure Description: Sum of 7 variables: frequency of hallucinations, reality of hallucinations, loudness of hallucinations, number of acoustically distinct voices, length of hallucinations, attentional salience of hallucinations, level of distress induced by hallucinations; higher score connotes more severe hallucinations; lowest score is 4, highest score is 37

Outcome Measures 

Go to  1.Primary Outcome

Title	Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions
Description	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
Time Frame	After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

 Outcome Measure Data

 Analysis Population Description

Last Observation Carried Forward (LOCF)

Arm/Group Title	Active Repetitive Transcanial Magnetic Stimulation	Placebo
Arm/Group Description:	Participants received active repetitive transcranial magnetic stimulation (rTMS)	Participants received sham stimulation
Overall Number of Participants Analyzed	27	23
Mean (Standard Deviation) Unit of Measure: Units on a scale
	5.85  (2.85)	8.61  (3.80)

 Statistical Analysis 1

2.Secondary Outcome

Title	Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions
Description	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.
Time Frame	After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

 Outcome Measure Data

 Analysis Population Description

LOCF

Arm/Group Title	Active Repetitive Transcanial Magnetic Stimulation	Placebo
Arm/Group Description:	Participants received active repetitive transcranial magnetic stimulation (rTMS)	Participants received sham stimulation
Overall Number of Participants Analyzed	27	23
Mean (Standard Deviation) Unit of Measure: Score on a scale
	1.42  (1.49)	.15  (1.14)

 Statistical Analysis 1

3.Secondary Outcome

Title	Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions
Description	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
Time Frame	After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

 Outcome Measure Data

 Analysis Population Description

[Not Specified]

Arm/Group Title	Active Repetitive Transcanial Magnetic Stimulation	Placebo
Arm/Group Description:	Participants received active repetitive transcranial magnetic stimulation (rTMS)	Participants received sham stimulation
Overall Number of Participants Analyzed	26	22
Mean (Standard Deviation) Unit of Measure: Units on a scale
	2.84  (.845)	3.79  (.882)

 Statistical Analysis 1

4.Secondary Outcome

Title	Responder Status
Description	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
Time Frame	After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

 Outcome Measure Data

 Analysis Population Description

LOCF

Arm/Group Title	Active Repetitive Transcanial Magnetic Stimulation	Placebo
Arm/Group Description:	Participants received active repetitive transcranial magnetic stimulation (rTMS)	Participants received sham stimulation
Overall Number of Participants Analyzed	27	23
Measure Type: Number Unit of Measure: Participants
	14	4

 Statistical Analysis 1

Adverse Events

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Time Frame	Adverse event reporting was collected for the duration of the study (41 months)
Adverse Event Reporting Description	Adverse events were systematically collected with focused questions each day during the trial
Arm/Group Title	Active Repetitive Transcanial Magnetic Stimulation	Placebo
Arm/Group Description	Participants received active repetitive transcranial magnetic stimulation (rTMS)	Participants received sham stimulation
All-Cause Mortality
	Active Repetitive Transcanial Magnetic Stimulation	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	–/–	–/–
Serious Adverse Events
	Active Repetitive Transcanial Magnetic Stimulation	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/27 (0.00%)	0/23 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Active Repetitive Transcanial Magnetic Stimulation	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	16/27 (59.26%)	3/23 (13.04%)
Nervous system disorders
Headache * [1]	16/27 (59.26%)	3/23 (13.04%)
* Indicates events were collected by non-systematic assessment[1] Transient headache and responsive to acetaminophen

Limitations and Caveats

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[Not Specified]

More Information

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Certain Agreements 

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI’s rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Publications of Results:

Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, Carroll K, Krystal JH. Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 2005 Jul 15;58(2):97-104. doi: 10.1016/j.biopsych.2005.03.041.

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