Parkinson's Disease With Cognitive Impairment Clinical Trial
Official title:
The Effect of High Frequency Repetitive Transcranial Magnetic Stimulation on Cognitive Impairment in Parkinson's Disease
| Verified date | July 2020 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study aims to assess the therapeutic role of rTMS on parkinson's patients with cognitive impairment. Patients diagnosed with Parkinson's Disease and cognitive impairment will be recruited. All patients will be admitted and will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS for each hemisphere for 10 consecutive sessions totally over period of 10 days with repeated booster sessions every month during the period of follow up. The other will receive sham sessions.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | June 15, 2019 |
| Est. primary completion date | June 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years to 75 Years |
| Eligibility | Inclusion Criteria: - All patients with Parkinson's Disease who were diagnosed according to UK bank criteria for PD, Aged 45-75 years, with criteria for cognitive impairment (Mini-Mental Status Examination< 24), and consent obtained from the patient or his caregiver. Exclusion Criteria: - History of repeated head injury - History of repeated cerebrovascular strokes - History of defined encephalitis - Oculogyric crisis, supranuclear gaze palsy - Family history of more than one relative - History of drug intake as antipsychotics or 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) exposure - Moderate and Severe depression (Hamilton Depression Rating Scale score >16) - severe dysautonomia - Cerebellar signs - Babinski sign - Strictly unilateral features after 3 years - Hydrocephalus or intracranial lesion on neuroimaging - We also excludes patients with intracranial metallic devices or with pacemakers or any other device. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Assiut University | Assiut |
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Egypt,
Aarsland D, Andersen K, Larsen JP, Lolk A, Kragh-Sørensen P. Prevalence and characteristics of dementia in Parkinson disease: an 8-year prospective study. Arch Neurol. 2003 Mar;60(3):387-92. — View Citation
Aarsland D, Ballard C, Rongve A, Broadstock M, Svenningsson P. Clinical trials of dementia with Lewy bodies and Parkinson's disease dementia. Curr Neurol Neurosci Rep. 2012 Oct;12(5):492-501. doi: 10.1007/s11910-012-0290-7. — View Citation
Aarsland D, Brønnick K, Fladby T. Mild cognitive impairment in Parkinson's disease. Curr Neurol Neurosci Rep. 2011 Aug;11(4):371-8. doi: 10.1007/s11910-011-0203-1. Review. — View Citation
Chaudhuri KR, Prieto-Jurcynska C, Naidu Y, Mitra T, Frades-Payo B, Tluk S, Ruessmann A, Odin P, Macphee G, Stocchi F, Ondo W, Sethi K, Schapira AH, Martinez Castrillo JC, Martinez-Martin P. The nondeclaration of nonmotor symptoms of Parkinson's disease to health care professionals: an international study using the nonmotor symptoms questionnaire. Mov Disord. 2010 Apr 30;25(6):704-9. doi: 10.1002/mds.22868. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | changes in Mini Mental State Examination (MMSE) | any changes in MMSE along the course of follow up (baseline, post treatment, one, two and three months later). Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (=9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. | three months | |
| Primary | changes in Montreal cognitive assessment scale (MoCA) | any changes of Montreal cognitive assessment scale (MoCA)along the course of follow up (baseline, post treatment, one, two and three months later). MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. In a study, people without cognitive impairment scored an average of 27.4; people with mild cognitive impairment (MCI) scored an average of 22.1; people with Alzheimer's disease scored an average of 16.2. | 3 months | |
| Primary | Event related potential P300 | changes in Event related potential P300 latency and amplitude (pre sessions -post sessions)As cognitive impairment elongates the P300 latency, we hypotheses that P300 could be a monitoring biomarker for rTMS effect, on cognitive function. | 10 days | |
| Secondary | motor part of Unified Parkinson's disease rating scale (UPDRS) | changes in motor part of Unified Parkinson's disease rating scale (UPDRS)along the course of follow up (baseline, post treatment, one, two and three months later) | 3 months | |
| Secondary | changes in cortical excitability | changes in cortical excitability (baseline, post treatment) | 10 days |