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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05759403
Collaborator
(none)
40
1
12.9
3.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cortical excitability using transcranial magnetic stimulation

Detailed Description

Parkinson's disease (PD), is one of the commonest neurodegenerative disorders with a severe progressive course and major impact on patients' quality of life. The development of late-onset PD likely results from the interaction of genetic and environmental factors in the context of brain aging.

Although several environmental exposures have been implicated, evidence for their causal contributions is limited.

PD in Egypt is a rapidly emerging concern as prevalence rose by 40.7% between 1990 and 2016, one of the highest increases in the world. which influences us to dig further in the genetic basis behind the scenes leading to that leap.

Cognitive impairment in PD constitutes a major source of disease burden for patients and families, and has a significant negative effect on patients' quality of life. Cognitive impairment without dementia is designated as mild cognitive impairment of PD (PD-MCI), where the activities of daily living are grossly preserved, whereas dementia associated with PD is designated as PD-D.

Parkinson's disease dementia is a neurofibrillary tangle degeneration involving the deposition of Alzheimer-type tau, predominantly in the mesial temporal cortex, brainstem, and basal ganglia.

The prevalence of Parkinson's Disease Dementia (PD-D) in the general population aged 65 years and over was 0.3 to 0.5%, and 3 to 4% of patients with dementia in the general population were estimated to be due to PD-D.

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Comparative Study Between Parkinson's Disease and Parkinson Dementia Complex : Genetics, Clinical, Neurophysiological
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients with parkinson's disease

Genetic analysis, clinical data , cortical excitbility

Diagnostic Test: Cortical excitability using transcranial magnetic stimulation
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 dementia complex

Genetic analysis, clinical data , cortical excitbility

Diagnostic Test: Cortical excitability using transcranial magnetic stimulation
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.

Outcome Measures

Primary Outcome Measures

  1. Score on MDS-UPDRS [through study completion, an average of 1 year]

    Score on MDS-UPDRS

  2. Score on mini mental state examination [through study completion, an average of 1 year]

    Score on mini mental state examination

Secondary Outcome Measures

  1. Score on PDQ-39 [through study completion, an average of 1 year]

    Score on PDQ-39

  2. Score on Score on Montreal Cognitive Assessment [through study completion, an average of 1 year]

    Score on Score on Montreal Cognitive Assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • All participants must fulfill the following inclusion criteria of UINTED KINGDOM bank criteria of PD Men or women of at least 50-80 years of age.

  • 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

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university hospital Assiut Egypt 12345

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eman M. Khedr, Professor doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05759403
Other Study ID Numbers:
  • TMS in Parkinson's
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2023