Schizophrenia Clinical Trial
Official title:
Empirical Validation of a Cerebellar-cortical Hallucination Circuit
Verified date | March 2024 |
Source | Mclean Hospital |
Contact | Mark Halko, PhD |
mhalko[@]mclean.harvard.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study how hallucinations work in schizophrenia. TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study the investigators will be stimulating the brain to learn more about how TMS might improve these symptoms of schizophrenia.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | October 31, 2026 |
Est. primary completion date | October 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Diagnosis of schizophrenia or schizoaffective disorder Exclusion Criteria: - substance use disorder in past 3 months - ambidexterity - contraindications for TMS or MRI including : - history of neurological disorder - history of head trauma resulting in loss of consciousness - history of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy - metal in brain or skull - implanted devices such as a pacemaker, medication pump, nerve stimulator or ventriculoperitoneal shunt - claustrophobic in MRI |
Country | Name | City | State |
---|---|---|---|
United States | McLean Hospital | Belmont | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital | Beth Israel Deaconess Medical Center, National Institute of Mental Health (NIMH) |
United States,
Basavaraju R, Ithal D, Thanki MV, Ramalingaiah AH, Thirthalli J, Reddy RP, Brady RO Jr, Halko MA, Bolo NR, Keshavan MS, Pascual-Leone A, Mehta UM, Kesavan M. Intermittent theta burst stimulation of cerebellar vermis enhances fronto-cerebellar resting state functional connectivity in schizophrenia with predominant negative symptoms: A randomized controlled trial. Schizophr Res. 2021 Dec;238:108-120. doi: 10.1016/j.schres.2021.10.005. Epub 2021 Oct 12. — View Citation
Brady RO Jr, Beermann A, Nye M, Eack SM, Mesholam-Gately R, Keshavan MS, Lewandowski KE. Cerebellar-Cortical Connectivity Is Linked to Social Cognition Trans-Diagnostically. Front Psychiatry. 2020 Nov 4;11:573002. doi: 10.3389/fpsyt.2020.573002. eCollection 2020. — View Citation
Brady RO Jr, Gonsalvez I, Lee I, Ongur D, Seidman LJ, Schmahmann JD, Eack SM, Keshavan MS, Pascual-Leone A, Halko MA. Cerebellar-Prefrontal Network Connectivity and Negative Symptoms in Schizophrenia. Am J Psychiatry. 2019 Jul 1;176(7):512-520. doi: 10.1176/appi.ajp.2018.18040429. Epub 2019 Jan 30. — View Citation
Halko MA, Farzan F, Eldaief MC, Schmahmann JD, Pascual-Leone A. Intermittent theta-burst stimulation of the lateral cerebellum increases functional connectivity of the default network. J Neurosci. 2014 Sep 3;34(36):12049-56. doi: 10.1523/JNEUROSCI.1776-14.2014. — View Citation
Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. — View Citation
Hwang M, Roh YS, Talero J, Cohen BM, Baker JT, Brady RO, Ongur D, Shinn AK. Auditory hallucinations across the psychosis spectrum: Evidence of dysconnectivity involving cerebellar and temporal lobe regions. Neuroimage Clin. 2021;32:102893. doi: 10.1016/j.nicl.2021.102893. Epub 2021 Nov 24. — View Citation
Nawaz U, Lee I, Beermann A, Eack S, Keshavan M, Brady R. Individual Variation in Functional Brain Network Topography is Linked to Schizophrenia Symptomatology. Schizophr Bull. 2021 Jan 23;47(1):180-188. doi: 10.1093/schbul/sbaa088. — View Citation
Ward HB, Brady RO Jr, Halko MA. Bridging the Gap: Strategies to Make Psychiatric Neuroimaging Clinically Relevant. Harv Rev Psychiatry. 2021 May-Jun 01;29(3):185-187. doi: 10.1097/HRP.0000000000000295. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | functional connectivity | change in functional connectivity of a putative cerebellar-thalamic-cortical hallucination circuit (cerebellum to thalamus) will be assessed before and after (1 week followup) TMS stimulation. | baseline, 1 week after TMS | |
Primary | Positive and Negative Syndrome Scale (PANSS) | The PANSS is clinical rating scale of symptom severity . Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms). | baseline | |
Primary | Scale for the Assessment of Positive Symptoms (SAPS) | The SAPS is clinical rating scale of symptom severity . Each descriptor is rated on a 5 point scale from 1=(absence of any symptom) to 5=(extremely severe symptoms). | baseline | |
Primary | Auditory Hallucination Rating Scale (AHRS) Scale (AHRS) | The AHRS is a 7-item clinical rating scale used to assess auditory hallucinations. | baseline |
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