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cTBS for Pareidolias

Investigating the effects of a single continuous theta burst stimulation (cTBS) to the frontal lobes in Parkinson's disease patients with pareidolia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052210061
Enrollment
30
Registered
2021-08-06
Start date
2021-08-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkioson Disease Parkinson Disease, Pareidolia

Interventions

Single-session stimulation of continuous theta burst magnetic stimulation (cTBS) under neuronavigation system guidance: triple pulses at 20 ms intervals repeated every 200 ms for 40 s for a total of 6
Transcranial Magnetic Stimulation

Sponsors

Kimura Yasuyoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Diagnosed with Parkinson's disease according to MDS diagnosis criteria 2) Age between 40 and 80 years at the time of consent. 3) Diagnosed by NPT as having mild hallucinations (cut-off value: 2) 4) Consent has been obtained in writing by the patient. 5) The severity in the ON condition is less than or equal to 3 according to the modified Hoehn-Yahr scale and requires dopaminergic drug treatment with either levodopa, a dopamine agonist, or MAO-B inhibitor. 6) Stable medication for Parkinson's disease and anticholinesterase drugs (donepezil, rivastigmine, galantamine) within 30 days prior to the date of consent. 7) Able to remain ON antiparkinsonian medication for the duration of the study (>2 hours) 8) The education in socioeconomic status is at least a secondary school diploma. 9) Have normal visual acuity with naked or corrected vision (Snellen index of 20/30 or less)

Exclusion criteria

Exclusion criteria: 1) Has cognitive decline (score 23 or below on MMSE) 2) Severe depressive symptoms (score of 28 or higher on BDI-II). Or BDI-II falls between 17 and 28 points and (1) scores at least 1 point on Question 9 (suicide question), or (2) is being treated for depression, or (3) the physician determines that depression will affect the evaluation or protocol. If (1) applies or if the depression is severe, the patient should be consulted by a psychiatrist or psychosom atic medicine specialist. 3) Taking antipsychotic drugs (olanzapine, risperidone, clozapine), anticholinesterase drugs (donepezil, rivastigmine, galantamine). 4) Taking antipsychotics or other medications with the potential to cause parkinsonism within 60 days prior to enrollment in this study. 5) Atypical symptoms of Parkinson's disease, such as cerebellar symptoms, pyramidal tract signs, autonomic neuropathy, or supranuclear ocular dyskinesia, are present at the time of diagnosis or occur within 1 month of diagnosis. 6) A history of seizures, epilepsy, or unexplained loss of consciousness. 7) History of fainting spells. 8) Has been diagnosed as having an abnormal brain structure 9) Have metal implants implanted in the skull or spinal cord due to neurosurgery, etc. 10) Has a pacemaker, artificial heart, vagus nerve stimulator, deep brain stimulator, or ventricular shunt implanted in the body 11) Pregnant 12) Have received repetitive transcranial magnetic stimulation in the past 13) Have received electroconvulsive therapy in the past 14) Poorly controlled diabetes, heart disease or hypertension 15) Taking any medication not indicated for TMS at the time of enrollment in the study (imipramine, amitriptyline, doxepin, nortriptyline, maprofiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines (MDMA, ecstasy), Cocaine, phencyclidine, ketamine, gamma-hydroxybutyrate (GHB), theophylline, haloperidol) 16) There is dyskinesia that affects the quality of the evalutaion. 17) Other items that the principal investigator or sub-investigator deems inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
Amount of change in pareidolia score in NPT performed before and after cTBS stimulation

Secondary

MeasureTime frame
1) Safety - reports of adverse events since the start of cTBS 2) B-JLO - change in Benton's linear orientation judgment test score 3) sSTAI - change in a simplified state-trait anxiety test score 4) EEG at rest and during NPT (eyes closed) 5) Face discrimination (D-prime) in NPT 6) Time spent gazing into the pareidolia / face area in the gaze measurement in NPT

Contacts

Public ContactYasuyoshi Kimura

Osaka University Hospital

y-kimura@neurol.med.osaka-u.ac.jp+81-6-6879-3571

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026