Clinical trial NCT04548622: Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations Results
Official title: Bilateral rTMS Clinical Trial for Persistent Auditory Hallucinations Results for a Terminated Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizoaffective disorder
Auditory Hallucinations
Voices
Repetitive Transcranial Magnetic Stimulation
rTMS
Wernicke's Area
Middle Temporal Cortex
Persistent Auditory Hallucinations
Previously Participated in "Parent" rTMS Protocol
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-09-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study was to conduct fMRI neuroimaging studies prior to and subsequent to the rTMS intervention. The intent was to ascertain changes in regional brain activation and connectivity that most robustly predict level of improvement in auditory hallucinations elicited by bilateral rTMS as assessed by the primary outcome variables.

Detailed description: This study is an extension of previous clinical trials (NCT00308997 and NCT00567281) that were initiated in 2006. This study record provides the results for the amended study NCT00567281 (originally called a 'third arm') that was discontinued following the passing of Dr. Ralph Hoffman. The primary purpose of the study was to conduct fMRI neuroimaging studies prior to and subsequent to the rTMS intervention. The intent was to ascertain changes in regional brain activation and connectivity that most robustly predict level of improvement in auditory hallucinations elicited by bilateral rTMS as assessed by our primary outcome variables. It was hoped that this combined fMRI/rTMS study would provide critical new insights into the neurobiological basis of auditory hallucinations.

The results presented are what was summarized following Dr. Hoffman's passing and were compiled by Dr. Philip Corlett.

Eligibility criteria: Inclusion Criteria:

* Previously enrolled in our "parent" rTMS trial with passage of at least six months since last received active rTMS

Exclusion Criteria:

* Active substance abuse or alcohol abuse
* Pregnancy
* Dose or type of psychiatric medication changed within the 4 weeks prior to study entry
* Recent head trauma, seizures, or significant unstable medical condition

Primary outcomes:
measure: PANSS Composite Positive Symptoms Hallucination Score
timeFrame: baseline to 4 weeks
measure: PANSS Composite Negative Symptom Scale
timeFrame: baseline to 4 weeks
measure: PANSS Total Score
timeFrame: baseline to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Department of Psychiatry, Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University Department of Psychiatry
name: Philip Corlett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hoffman RE, Boutros NN, Hu S, Berman RM, Krystal JH, Charney DS. Transcranial magnetic stimulation and auditory hallucinations in schizophrenia. Lancet. 2000 Mar 25;355(9209):1073-5. doi: 10.1016/S0140-6736(00)02043-2.
citation: Hoffman RE, Hampson M, Wu K, Anderson AW, Gore JC, Buchanan RJ, Constable RT, Hawkins KA, Sahay N, Krystal JH. Probing the pathophysiology of auditory/verbal hallucinations by combining functional magnetic resonance imaging and transcranial magnetic stimulation. Cereb Cortex. 2007 Nov;17(11):2733-43. doi: 10.1093/cercor/bhl183. Epub 2007 Feb 13.
citation: Hoffman RE, Anderson AW, Varanko M, Gore JC, Hampson M. Time course of regional brain activation associated with onset of auditory/verbal hallucinations. Br J Psychiatry. 2008 Nov;193(5):424-5. doi: 10.1192/bjp.bp.107.040501.