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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04210557
Other study ID # 2000023640
Secondary ID 1R21MH116258-01A
Status Terminated
Phase N/A
First received
Last updated
Start date February 27, 2020
Est. completion date April 1, 2021

Study information

Verified date February 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to address the shortcoming in clinical hallucination research by causally manipulating the neural loci of conditioned hallucination task behavior in-person in patients with psychosis using transcranial magnetic stimulation (TMS), tracking the impact of this manipulation on the number of times participants with hallucinations report hearing tones that were not presented. With such a causal intervention, the veracity of this explanation of hallucinations will be either validated or disconfirmed. If validated, the task can be further developed as a biomarker for predicting the hallucination onset, guiding, developing or tracking the effects of treatments for hallucinations.


Description:

Hallucinations are percepts without stimulus. 70% of patients with schizophrenia suffer distressing auditory hallucinations. Their mere presence increases the risk of suicide. Most reach remission with D2 dopamine receptor blocking drugs after 1 year of adherence. However, 30% of patients have intractable hallucinations, and 50% are non-adherent to their medications, commonly because of unfavorable side-effects - those intractable and non-adherent patients continue to suffer. There is a clear need for a mechanistic understanding of hallucinations as a prelude to rational treatment design. This study provides the initial steps towards the development of an interventional biomarker for clinical hallucinations, grounded in computational neuroscience. Computational psychiatry involves harnessing the power of computational neuroscience to address the clinical needs of those suffering from serious mental illnesses. There has been much discussion of the promise of the approach. There have been few studies thus far and they have largely involved correlative methods like functional neuroimaging. This study will address this shortcoming by causally manipulating the neural loci of computational model parameters in-person in patients with psychosis using transcranial magnetic stimulation (TMS), tracking the impact of this manipulation on behavioral task performance . With such a causal intervention, the veracity of the model's explanation of hallucinations will be either validated or disconfirmed. If validated, the model can be further developed as a biomarker for predicting the hallucination onset, guiding, developing or tracking the effects of treatments for hallucinations. If disconfirmed, the model ought to be discarded and other alternatives should be pursued.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date April 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Aged 18 - 45 years - Voice hearing patients - Meet diagnostic criteria for DSM-V schizophrenia or schizophreniform disorder - Report hearing voices at least once a day - Score > 3 on PANSS P3 (hallucinations item) Exclusion Criteria: - DSM-V substance use disorder within the past 6 months - Previous head injury with neurological symptoms and/or unconsciousness - Intellectual disability (IQ < 70) - Non-English speaker - Contraindications for TMS, including: - History of seizures - Metallic implants - Pacemaker - Pregnancy - Less than 6 weeks of a stable dose of psychotropic medication(s) - Comorbid mood or anxiety diagnosis - Clinically/behaviorally instability and unable to cooperate with TMS procedures - Clinically significant medical condition(s) - Unstable medical condition(s) based on EKG, medical history, physical examination, and routine lab work - Personal history of stroke - Family history of seizures

Study Design


Intervention

Device:
Transcranial Magnetic Stimulation (TMS)
Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. An electric pulse generator, or stimulator, is connected to a magnetic coil, which in turn is connected to the scalp. The stimulator generates a changing electric current within the coil which induces a magnetic field; this field then causes a second inductance of inverted electric charge within the brain itself.

Locations

Country Name City State
United States Connecticut Mental Health Center (CMHC) New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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* Note: There are 60 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Conditioned Hallucinations Task Performance The primary outcome measure is the number of times participants report hearing tones that were not presented. There are 360 total trials. There are 120 no tone trials. People who hear voices typically report hearing tones on 30% of the no tone trials (approximately 36 times, as compared to 12 times in people who do not hear voices). The investigators anticipate fewer conditioned hallucinations (fewer than 36 reports of tones when none were presented) in the active TMS conditions as compared to the sham. approximately 13 months
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