The Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive Impairment in Parkinson's Disease (PD)

NCT03879551 | Completed

• 1 other identifier: rTMS and cognition in PD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease With Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• motor part of Unified Parkinson's disease rating scale (UPDRS)

  3 months

• changes in cortical excitability

  10 days

Study Arms (2)

Real rTMS

ACTIVE COMPARATOR

Real rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere on the hand motor area for 10 consecutive sessions totally over period of 10 days.

Device: repetitive Transcranial Magnetic Stimulation

Sham rTMS

SHAM COMPARATOR

Sham rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere with coil perpendicular on scalp for 10 consecutive sessions totally over period of 10 days.

Device: repetitive Transcranial Magnetic Stimulation

Interventions

repetitive Transcranial Magnetic Stimulation DEVICE

By defining intensity of 80% of the resting Motor Threshold detected from motor area for Rt Abductor digiti minimi (ADM), we will apply repetitive Transcranial Magnetic Stimulation (rTMS) using 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magnetic Stimulator with high frequency (25Hz), Stimuli will be delivered for total 2000 pulse (divided on 50 trains with 40 pulses per train with inter-train interval 30 seconds) for each hemisphere (coil placed tangential over the optimal position of hand motor area detected for Real group and the same coil placed perpendicular with hand of coil pointing upward over occipital cortex for Sham group). Sessions will be consecutive for ten days period with repetition of consecutive 5 sessions as boosting doses on 5 days period over the follow up visits every month for the next 3 months.

Also known as: rTMS

Real rTMS; Sham rTMS

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 11517, Egypt

Location

Related Publications (5)

• Aarsland D, Andersen K, Larsen JP, Lolk A, Kragh-Sorensen P. Prevalence and characteristics of dementia in Parkinson disease: an 8-year prospective study. Arch Neurol. 2003 Mar;60(3):387-92. doi: 10.1001/archneur.60.3.387.

  PMID: 12633150 BACKGROUND

• Aarsland D, Bronnick 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.

  PMID: 21487730 BACKGROUND

• 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.

  PMID: 22806065 BACKGROUND

• 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.

  PMID: 20437539 BACKGROUND

• Khedr EM, Mohamed KO, Ali AM, Hasan AM. The effect of repetitive transcranial magnetic stimulation on cognitive impairment in Parkinson's disease with dementia: Pilot study. Restor Neurol Neurosci. 2020;38(1):55-66. doi: 10.3233/RNN-190956.

  PMID: 31815705 DERIVED

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Eman Khedr, Professor

  Neurology Department, Faculty of Medicine, Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asmaa Mohamed Mohamed Mahmoud Hasan Assistant Lecturer of Neurology

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: March 15, 2019
• Primary Completion: June 15, 2019
• Study Completion: June 15, 2019
• Last Updated: December 21, 2021

Record last verified: 2020-07

Locations

EG (1)