Comparison Between Parkinson's Disease and Parkinson's Dementia Complex (Genetically,Clinical and Electrophysiological)

NCT05759403 | Unknown DMC

• 1 other identifier: TMS in Parkinson's
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To compare between Idiopathic PD versus Parkinson-Dementia complex using different modalities: Demographic, Clinical, genetic, Psychometric and electrophysiologically

Conditions

Parkinson Disease Dementia; Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Score on MDS-UPDRS

  Score on MDS-UPDRS

  through study completion, an average of 1 year

• Score on mini mental state examination

  Score on mini mental state examination

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Score on PDQ-39

  through study completion, an average of 1 year

• Score on Score on Montreal Cognitive Assessment

  through study completion, an average of 1 year

Study Arms (2)

Patients with parkinson's disease

Genetic analysis, clinical data , cortical excitbility

Diagnostic Test: Cortical excitability using transcranial magnetic stimulation

patients with Parkinson dementia complex

Genetic analysis, clinical data , cortical excitbility

Diagnostic Test: Cortical excitability using transcranial magnetic stimulation

Interventions

Cortical excitability using transcranial magnetic stimulation DIAGNOSTIC_TEST

Transcranial magnetic stimulation (TMS) is a noninvasive neurophysiological technique for assessing human motor cortical function. With TMS, the underlying motor cortex is stimulated by an electric current induced by a transient magnetic field, generated in response to the passage of a large current through the stimulating coil located on the patient's scalp.

Patients with parkinson's disease; patients with Parkinson dementia complex

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with parkinson's disease and parkinson dementia complex

You may qualify if:

• Are reliable and willing to make themselves available for the duration of the study and are willing to follow up.
• Medically stable outpatients with confirmed diagnosis of idiopathic PD according to United Kingdom Brain Bank Criteria
• Clear written informed consent from each participant in the trial.
• Patients after at least 6 h free of parkinsonian drugs (off-state).
• For the Parkinson's Dementia Complex group, dementia must be evident through history taking or clinical examination

You may not qualify if:

• Pregnants, breastfeeding, or willing to be pregnant during the study.
• Presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study
• Participation in any other type of medical research that may interfere with the interpretation of the study.
• Patients with severe motor disability (bed-ridden ) that may interfere with the study procedure.
• History of surgical or invasive intervention for Parkinson disease.
• Patients with history of seizures or epilepsy including history in a first degree relative or patients on treatment that reduce seizure threshold.
• For the Parkinson's Dementia Complex group, Subject with dementia due to other diseases or with Parkinson's dementia complex and contribution of other disorders (Mixed dementia)
• Brain imaging suggesting another diagnosis.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 12345, Egypt

RECRUITING

Related Publications (13)

• Chen H, Ritz B. The Search for Environmental Causes of Parkinson's Disease: Moving Forward. J Parkinsons Dis. 2018;8(s1):S9-S17. doi: 10.3233/JPD-181493.

  PMID: 30584168 BACKGROUND

• Ball N, Teo WP, Chandra S, Chapman J. Parkinson's Disease and the Environment. Front Neurol. 2019 Mar 19;10:218. doi: 10.3389/fneur.2019.00218. eCollection 2019.

  PMID: 30941085 BACKGROUND

• Priyadarshi A, Khuder SA, Schaub EA, Priyadarshi SS. Environmental risk factors and Parkinson's disease: a metaanalysis. Environ Res. 2001 Jun;86(2):122-7. doi: 10.1006/enrs.2001.4264.

  PMID: 11437458 BACKGROUND

• Bellou V, Belbasis L, Tzoulaki I, Evangelou E, Ioannidis JP. Environmental risk factors and Parkinson's disease: An umbrella review of meta-analyses. Parkinsonism Relat Disord. 2016 Feb;23:1-9. doi: 10.1016/j.parkreldis.2015.12.008. Epub 2015 Dec 17.

  PMID: 26739246 BACKGROUND

• GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.

  PMID: 30879893 BACKGROUND

• Sezgin M, Bilgic B, Tinaz S, Emre M. Parkinson's Disease Dementia and Lewy Body Disease. Semin Neurol. 2019 Apr;39(2):274-282. doi: 10.1055/s-0039-1678579. Epub 2019 Mar 29.

  PMID: 30925619 BACKGROUND

• Morris HR, Steele JC, Crook R, Wavrant-De Vrieze F, Onstead-Cardinale L, Gwinn-Hardy K, Wood NW, Farrer M, Lees AJ, McGeer PL, Siddique T, Hardy J, Perez-Tur J. Genome-wide analysis of the parkinsonism-dementia complex of Guam. Arch Neurol. 2004 Dec;61(12):1889-97. doi: 10.1001/archneur.61.12.1889.

  PMID: 15596609 BACKGROUND

• Aarsland D, Zaccai J, Brayne C. A systematic review of prevalence studies of dementia in Parkinson's disease. Mov Disord. 2005 Oct;20(10):1255-63. doi: 10.1002/mds.20527.

  PMID: 16041803 BACKGROUND

• Chen R, Cros D, Curra A, Di Lazzaro V, Lefaucheur JP, Magistris MR, Mills K, Rosler KM, Triggs WJ, Ugawa Y, Ziemann U. The clinical diagnostic utility of transcranial magnetic stimulation: report of an IFCN committee. Clin Neurophysiol. 2008 Mar;119(3):504-532. doi: 10.1016/j.clinph.2007.10.014. Epub 2007 Dec 11.

  PMID: 18063409 BACKGROUND

• Rossini PM, Barker AT, Berardelli A, Caramia MD, Caruso G, Cracco RQ, Dimitrijevic MR, Hallett M, Katayama Y, Lucking CH, et al. Non-invasive electrical and magnetic stimulation of the brain, spinal cord and roots: basic principles and procedures for routine clinical application. Report of an IFCN committee. Electroencephalogr Clin Neurophysiol. 1994 Aug;91(2):79-92. doi: 10.1016/0013-4694(94)90029-9. No abstract available.

  PMID: 7519144 BACKGROUND

• Ziemann U, Netz J, Szelenyi A, Homberg V. Spinal and supraspinal mechanisms contribute to the silent period in the contracting soleus muscle after transcranial magnetic stimulation of human motor cortex. Neurosci Lett. 1993 Jun 25;156(1-2):167-71. doi: 10.1016/0304-3940(93)90464-v.

  PMID: 8414181 BACKGROUND

• Chen R, Lozano AM, Ashby P. Mechanism of the silent period following transcranial magnetic stimulation. Evidence from epidural recordings. Exp Brain Res. 1999 Oct;128(4):539-42. doi: 10.1007/s002210050878.

  PMID: 10541749 BACKGROUND

• Daskalakis ZJ, Christensen BK, Chen R, Fitzgerald PB, Zipursky RB, Kapur S. Evidence for impaired cortical inhibition in schizophrenia using transcranial magnetic stimulation. Arch Gen Psychiatry. 2002 Apr;59(4):347-54. doi: 10.1001/archpsyc.59.4.347.

  PMID: 11926935 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for genetic analysis

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: March 8, 2023
• Study Start: November 1, 2022
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-02

Locations

EG (1)