NCT06289855

Brief Summary

The goal of this observational study is to learn about impulse control disorders in Parkinson's disease patients. The main question: it aims to answer:

  • Detect Relative frequency of impulse control disorder among Parkinson's disease patients
  • Detect Relation between impulse control disorders, and other non motor and motor symptoms in Parkinson's disease patients, using clinical, neurophysiological and radiological assessment

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

February 26, 2024

Last Update Submit

March 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of patients with impulse control disorder among Parkinson's disease patients

    Relative frequency of impulse control disorder among Parkinson's disease patients, and comparing those with impulse control and those without impulse control disorder, clinically and neurophysiologically

    1 year

Secondary Outcomes (3)

  • percent of cognition affection, gait affection among patients with impulse control disorder among Parkinson's disease patients

    1 year

  • volume of cortex and basal ganglia in patients with impulse control disorder among Parkinson's disease patients

    1 year

  • cortical excitability and inhibition inpatients with impulse control disorder among Parkinson's disease patients

    1 year

Interventions

Movement disorder society- unified Parkinson disease rating scale (MDS-UPDRS) for Parkinson's disease. Movement disorder society- non motor rating scale (MDS-NMS) Cognitive assessment using Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-Cog) Using Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale: Timed up and go: originally aimed to clinically evaluate dynamic balance in elderly people during the performance of a task MR imaging of the brain will be performed with a 1.5T MR imaging scanner Assessment of Cortical excitability and unhibition by NIHON KOHDEN- neuropack2

Also known as: MDS-NMS, SCOPA-Cog, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale, Timed up and go, MR imaging of the brain, cortical excietability

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Parkinson's disease attending Assiut University neurology outpatient clinic and internal department

You may qualify if:

  • The study will include patients with Parkinson's disease, diagnosed according to the UK Parkinson's Disease Society Brain Bank criteria. (16)
  • Bradykinesia (slowness of initiation of voluntary movements with progressive reduction in speed and amplitude of repetitive actions).
  • And at least one of the following: Muscular rigidity, 4-6 Hz rest tremor Postural instability not caused by primary visual, vestibular, cerebellar or proprioceptive dysfunction

You may not qualify if:

  • History of strokes with stepwise progression of Parkinsonian features.
  • History of head injury.
  • History of definite encephalitis.
  • Oculogyric crises.
  • Neuroleptic treatment at onset of symptoms.
  • Strictly unilateral features after three years.
  • Supranuclear gaze palsy.
  • Cerebellar signs.
  • Early severe autonomic involvement.
  • Early severe dementia with disturbances of memory, language and praxis.
  • Babinski sign.
  • Presence of a cerebral tumor or communicating hydrocephalus on CT scan.
  • Negative response to large doses of levodopa (if malabsorption excluded).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Martin-Bastida A, Delgado-Alvarado M, Navalpotro-Gomez I, Rodriguez-Oroz MC. Imaging Cognitive Impairment and Impulse Control Disorders in Parkinson's Disease. Front Neurol. 2021 Nov 5;12:733570. doi: 10.3389/fneur.2021.733570. eCollection 2021.

  • Jellinger KA. Neuropathobiology of non-motor symptoms in Parkinson disease. J Neural Transm (Vienna). 2015 Oct;122(10):1429-40. doi: 10.1007/s00702-015-1405-5. Epub 2015 May 15.

  • Weintraub D, Koester J, Potenza MN, Siderowf AD, Stacy M, Voon V, Whetteckey J, Wunderlich GR, Lang AE. Impulse control disorders in Parkinson disease: a cross-sectional study of 3090 patients. Arch Neurol. 2010 May;67(5):589-95. doi: 10.1001/archneurol.2010.65.

  • Cossu G, Rinaldi R, Colosimo C. The rise and fall of impulse control behavior disorders. Parkinsonism Relat Disord. 2018 Jan;46 Suppl 1:S24-S29. doi: 10.1016/j.parkreldis.2017.07.030. Epub 2017 Aug 1.

  • Grassi G, Albani G, Terenzi F, Razzolini L, Ramat S. New pharmacological and neuromodulation approaches for impulsive-compulsive behaviors in Parkinson's disease. Neurol Sci. 2021 Jul;42(7):2673-2682. doi: 10.1007/s10072-021-05237-8. Epub 2021 Apr 14.

  • Probst CC, van Eimeren T. The functional anatomy of impulse control disorders. Curr Neurol Neurosci Rep. 2013 Oct;13(10):386. doi: 10.1007/s11910-013-0386-8.

  • Menon V. Large-scale brain networks and psychopathology: a unifying triple network model. Trends Cogn Sci. 2011 Oct;15(10):483-506. doi: 10.1016/j.tics.2011.08.003. Epub 2011 Sep 9.

  • Lichter DG, Benedict RHB, Hershey LA. Importance of Balance-Gait Disorder as a Risk Factor for Cognitive Impairment, Dementia and Related Non-Motor Symptoms in Parkinson's Disease. J Parkinsons Dis. 2018;8(4):539-552. doi: 10.3233/JPD-181375.

  • Hyland BI, Seeger-Armbruster S, Smither RA, Parr-Brownlie LC. Altered Recruitment of Motor Cortex Neuronal Activity During the Grasping Phase of Skilled Reaching in a Chronic Rat Model of Unilateral Parkinsonism. J Neurosci. 2019 Nov 27;39(48):9660-9672. doi: 10.1523/JNEUROSCI.0720-19.2019. Epub 2019 Oct 22.

  • Ammann C, Dileone M, Pagge C, Catanzaro V, Mata-Marin D, Hernandez-Fernandez F, Monje MHG, Sanchez-Ferro A, Fernandez-Rodriguez B, Gasca-Salas C, Manez-Miro JU, Martinez-Fernandez R, Vela-Desojo L, Alonso-Frech F, Oliviero A, Obeso JA, Foffani G. Cortical disinhibition in Parkinson's disease. Brain. 2020 Dec 5;143(11):3408-3421. doi: 10.1093/brain/awaa274.

  • Bologna M, Guerra A, Paparella G, Giordo L, Alunni Fegatelli D, Vestri AR, Rothwell JC, Berardelli A. Neurophysiological correlates of bradykinesia in Parkinson's disease. Brain. 2018 Aug 1;141(8):2432-2444. doi: 10.1093/brain/awy155.

  • Guerra A, Suppa A, D'Onofrio V, Di Stasio F, Asci F, Fabbrini G, Berardelli A. Abnormal cortical facilitation and L-dopa-induced dyskinesia in Parkinson's disease. Brain Stimul. 2019 Nov-Dec;12(6):1517-1525. doi: 10.1016/j.brs.2019.06.012. Epub 2019 Jun 11.

  • Casarotto S, Turco F, Comanducci A, Perretti A, Marotta G, Pezzoli G, Rosanova M, Isaias IU. Excitability of the supplementary motor area in Parkinson's disease depends on subcortical damage. Brain Stimul. 2019 Jan-Feb;12(1):152-160. doi: 10.1016/j.brs.2018.10.011. Epub 2018 Oct 23.

  • Zhai H, Fan W, Xiao Y, Zhu Z, Ding Y, He C, Zhang W, Xu Y, Zhang Y. Voxel-based morphometry of grey matter structures in Parkinson's Disease with wearing-off. Brain Imaging Behav. 2023 Dec;17(6):725-737. doi: 10.1007/s11682-023-00793-3. Epub 2023 Sep 22.

  • Tessitore A, Santangelo G, De Micco R, Vitale C, Giordano A, Raimo S, Corbo D, Amboni M, Barone P, Tedeschi G. Cortical thickness changes in patients with Parkinson's disease and impulse control disorders. Parkinsonism Relat Disord. 2016 Mar;24:119-25. doi: 10.1016/j.parkreldis.2015.10.013. Epub 2015 Oct 20.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer, neurology department, Assiut university

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 4, 2024

Study Start

April 1, 2024

Primary Completion

August 31, 2024

Study Completion

March 31, 2025

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

The confidentiality of patient's information will be maintained throughout the study, only clinical data will be shared