Parkinson's DiseaseNCT06289855
Impulse Control Disorder Among Parkinson's Disease Patients
An observational study of Parkinson's Disease, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- MDS-UPDRS
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease attending Assiut University neurology outpatient clinic and internal department
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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).
About this study
Official title: Impulse Control Disorder Among Parkinson's Disease Patients; Clinical and Neurophysiological Study
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
Read the detailed description
Parkinson disease (PD), is a multisystem disease with motor and non-motor (NM) deficits. Dementia and mild forms of cognitive impairment as well as neuropsychiatric symptoms (i.e., impulse control disorders) are frequent and disabling non-motor symptoms of Parkinson's disease (PD). According to the fifth edition of the American Psychiatric Association's Diagnostic and Statistical Manual (DSM-5), impulse control disorders are defined as "disruptive, impulse-control, while conduct disorders include conditions involving problems in the self-control of emotions and behaviors".
Many studies have highlighted potential risk factors for these behaviors, including the fact that that ICDs are associated with younger age, male sex and younger age at disease onset. Also these behaviors have been consistently linked to the use of dopaminergic medications used to treat Parkinson's disease motor symptoms (dopamine agonists, levodopa, and other agents) and less consistently to neuro-modulation techniques such as deep brain stimulation (DBS).
Up to 14-17% of patients with Parkinson's disease display a set of impulsive-compulsive spectrum disorders during the course of illness. Once uncontrolled behaviors develop, either patients fail understand or recognize the severity of their actions or hide them in shame with devastating social and financial results for themselves and their families.
Previous neuropsychological studies have also demonstrated that impulse control disorders in Parkinson's disease are associated with an altered cognitive profile, characterized by impaired cognitive flexibility and planning capability as well as by more inappropriate behavior and poor feedback processes. Also, Cognitive impairment and dementia in particular are associated with adverse outcomes, including gait impairment and falls, greater disability and caregiver burden, higher economic costs, and increased mortality.
Motor deficits have been repeatedly associated with changes in the activity of the motor cortex, in patients with Parkinson's disease. A key regulator of cortical motor output is the balance between excitation and inhibition, which can be assessed in humans with transcranial magnetic stimulation (TMS) techniques.
A common measure to explore inhibitory mechanisms is the short-interval intracortical inhibition (SICI) induced by paired-pulse TMS stimuli. Several studies have described reduced SICI (i.e. less inhibition) in the motor cortex of patients with Parkinson's disease.
The development of neuroimaging techniques, including Voxel-based morphometry (VBM), which is an automated quantitative magnetic resonance imaging (MRI) technique extensively used to assess the grey matter (GM) morphology changes in the brain and has been widely used in Parkinson's disease. The majority of the studies focused on grey matter (GM) changes in Parkinson's disease associated with motor and non-motor symptoms.
Reduced cortical thickness of fronto-striatal regions has been reported as the key feature to differentiate Parkinson's disease with impulse control disorders from Parkinson's disease without impulse control disorders patients, but a concomitant increased amygdala volume and a positive relationship between impulse control disorders severity and middle frontal and parietal cortical volumes have been also shown. In addition, two studies showed an increased cortical thickness in meso-limbic regions and another one reported a relatively preserved grey matter in Parkinson's disease with impulse control disorders patients compared with Parkinson's disease without impulse control disorders cases. Also studies showed that changes in grey matter volume are associated with lack of inhibition related to impulse control disorders behaviors in Parkinson's disease.
Therefore; impulse control disorder is becoming an increasingly recognized psychiatric complication in Parkinson's disease; and whether or not it's associated with cortical dysfunction, and further cognitive and gait and balance affection, need further clinical, neurophysiological and radiological analysis, to further understand the underlying mechanism.
- Conditions
- Parkinson's Disease
- Being tested
- MDS-UPDRS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDS-UPDRSOther
Also called MDS-NMS, SCOPA-Cog, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale, Timed up and go
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
percent of cognition affection, gait affection among patients with impulse control disorder among Parkinson's disease patients
Relation between impulse control disorders, other non motor and motor symptoms in Parkinson's disease patients, using clinical, neurophysiological and radiological assessment
Measured: 1 year
volume of cortex and basal ganglia in patients with impulse control disorder among Parkinson's disease patients
detect cortical and subcortical volume by MRI volumetry
Measured: 1 year
cortical excitability and inhibition inpatients with impulse control disorder among Parkinson's disease patients
neurophysiological assessment of cortical excitability
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roaa Almoataz Abdelrazik Zohni Elsabrout, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289855
- Sponsor's protocol ID
- Parkinson's disease
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The confidentiality of patient's information will be maintained throughout the study, only clinical data will be shared
Publications
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.
PubMed 34803882Jellinger 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.
PubMed 25976432Weintraub 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.
PubMed 20457959Cossu 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.
PubMed 28818561Grassi 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.
PubMed 33852081Probst 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.
PubMed 23963609Menon 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.
PubMed 21908230Lichter 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.
PubMed 30124451Hyland 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.
PubMed 31641050Ammann 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.
PubMed 33141146Bologna 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.
PubMed 29901693Guerra 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.
PubMed 31217080Casarotto 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.
PubMed 30416036Zhai 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.
PubMed 37735325Tessitore 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.
PubMed 26810913
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impulse Control Disorder Among Parkinson's Disease Patients; Clinical and Neurophysiological Study
- ClinicalTrials.gov ID
- NCT06289855
- Acronym / sponsor ID
- Parkinson's disease
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Parkinson disease (PD), is a multisystem disease with motor and non-motor (NM) deficits. Dementia and mild forms of cognitive impairment as well as neuropsychiatric symptoms (i.e., impulse control disorders) are frequent and disabling non-motor symptoms of Parkinson's disease (PD). According to the fifth edition of the American Psychiatric Association's Diagnostic and Statistical Manual (DSM-5), impulse control disorders are defined as "disruptive, impulse-control, while conduct disorders include conditions involving problems in the self-control of emotions and behaviors".
Many studies have highlighted potential risk factors for these behaviors, including the fact that that ICDs are associated with younger age, male sex and younger age at disease onset. Also these behaviors have been consistently linked to the use of dopaminergic medications used to treat Parkinson's disease motor symptoms (dopamine agonists, levodopa, and other agents) and less consistently to neuro-modulation techniques such as deep brain stimulation (DBS).
Up to 14-17% of patients with Parkinson's disease display a set of impulsive-compulsive spectrum disorders during the course of illness. Once uncontrolled behaviors develop, either patients fail understand or recognize the severity of their actions or hide them in shame with devastating social and financial results for themselves and their families.
Previous neuropsychological studies have also demonstrated that impulse control disorders in Parkinson's disease are associated with an altered cognitive profile, characterized by impaired cognitive flexibility and planning capability as well as by more inappropriate behavior and poor feedback processes. Also, Cognitive impairment and dementia in particular are associated with adverse outcomes, including gait impairment and falls, greater disability and caregiver burden, higher economic costs, and increased mortality.
Motor deficits have been repeatedly associated with changes in the activity of the motor cortex, in patients with Parkinson's disease. A key regulator of cortical motor output is the balance between excitation and inhibition, which can be assessed in humans with transcranial magnetic stimulation (TMS) techniques.
A common measure to explore inhibitory mechanisms is the short-interval intracortical inhibition (SICI) induced by paired-pulse TMS stimuli. Several studies have described reduced SICI (i.e. less inhibition) in the motor cortex of patients with Parkinson's disease.
The development of neuroimaging techniques, including Voxel-based morphometry (VBM), which is an automated quantitative magnetic resonance imaging (MRI) technique extensively used to assess the grey matter (GM) morphology changes in the brain and has been widely used in Parkinson's disease. The majority of the studies focused on grey matter (GM) changes in Parkinson's disease associated with motor and non-motor symptoms.
Reduced cortical thickness of fronto-striatal regions has been reported as the key feature to differentiate Parkinson's disease with impulse control disorders from Parkinson's disease without impulse control disorders patients, but a concomitant increased amygdala volume and a positive relationship between impulse control disorders severity and middle frontal and parietal cortical volumes have been also shown. In addition, two studies showed an increased cortical thickness in meso-limbic regions and another one reported a relatively preserved grey matter in Parkinson's disease with impulse control disorders patients compared with Parkinson's disease without impulse control disorders cases. Also studies showed that changes in grey matter volume are associated with lack of inhibition related to impulse control disorders behaviors in Parkinson's disease.
Therefore; impulse control disorder is becoming an increasingly recognized psychiatric complication in Parkinson's disease; and whether or not it's associated with cortical dysfunction, and further cognitive and gait and balance affection, need further clinical, neurophysiological and radiological analysis, to further understand the underlying mechanism.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease attending Assiut University neurology outpatient clinic and internal department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDS-UPDRSAlso: MDS-NMS, SCOPA-Cog, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale, Timed up and goMovement 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 | Other | – |
Primary outcome
number of patients with impulse control disorder among Parkinson's disease patients
Time frame: 1 year
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
3 secondary outcomes
percent of cognition affection, gait affection among patients with impulse control disorder among Parkinson's disease patients
Time frame: 1 year
volume of cortex and basal ganglia in patients with impulse control disorder among Parkinson's disease patients
Time frame: 1 year
cortical excitability and inhibition inpatients with impulse control disorder among Parkinson's disease patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Results publication: PubMed 34803882Martin-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.
- Results publication: PubMed 25976432Jellinger 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.
- Results publication: PubMed 20457959Weintraub 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.
- Results publication: PubMed 28818561Cossu 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.
- Results publication: PubMed 33852081Grassi 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.
- Results publication: PubMed 23963609Probst 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.
- Results publication: PubMed 21908230Menon 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.
- Results publication: PubMed 30124451Lichter 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.
- Results publication: PubMed 31641050Hyland 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.
- Results publication: PubMed 33141146Ammann 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.
- Results publication: PubMed 29901693Bologna 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.
- Results publication: PubMed 31217080Guerra 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.
- Individual participant dataSharing planned: No. The confidentiality of patient's information will be maintained throughout the study, only clinical data will be shared
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with impulse control disorder among Parkinson's disease patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06289855, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.