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Completed

NCT Number: NCT03879551

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

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.

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Key information

Conditions

Parkinson's Disease With Cognitive Impairment

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, 11517, Egypt

About this study

This study aims to assess the therapeutic role of rTMS on parkinson's patients with cognitive impairment. Thirty PD patients with cognitive impairment using United Kingdom (UK ) bank criteria for PD will be recruited from outpatient clinic in Assiut University. All patients will be admitted at Neuropsychiatric Department, Assiut University Hospital/ Assiut, Egypt.Each patient fulfilled the inclusion criteria as having score less than 24 on Mini-Mental Status Examination will be recruited. The patients will be allocated randomly into two groups one of which will receive real sessions of high frequency rTMS (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days with repeated booster session every month during the period of follow up among three months. The other will receive sham sessions. All subjects will be followed up by selected clinical rating scales at different intervals pre session, post 10 sessions, and after one, two and three months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: rTMS

Primary outcomes

  1. changes in Mini Mental State Examination (MMSE)

    Time frame: three months

    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.

  2. changes in Montreal cognitive assessment scale (MoCA)

    Time frame: 3 months

    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. Event related potential P300

    Time frame: 10 days

    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.

Secondary outcomes

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

    Time frame: 3 months

    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)

  2. changes in cortical excitability

    Time frame: 10 days

    changes in cortical excitability (baseline, post treatment)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Effect of High Frequency Repetitive Transcranial Magnetic Stimulation on Cognitive Impairment in Parkinson's Disease

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2019
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.