cTBS for Pareidolias

JRCT ID: jRCTs052210061

Registered date:06/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkioson Disease
• Date of first enrollment: 06/08/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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 600 pulses are used for transcranial repetitive magnetic stimulation (TMS) to the right dorsolateral prefrontal cortex. The stimulation intensity is 90% of active motor threshold (maximum stimulation intensity: 55% maximum stimulator output), and the stimulation conditions for sham stimulation are the same as for real stimulation except for the stimulus intensity (80% of real condition). The real and sham stimulation sessions should be separated by 1~8 weeks for each patient.

Outcome(s)

• Primary Outcome: Amount of change in pareidolia score in NPT performed before and after cTBS stimulation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 80age old
• Gender: Both

Include 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)

Exclude 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.

Related Information

• Primary Sponsor: Kimura Yasuyoshi
• Source(s) of Monetary Support: Japan Society for the Promotion of Science