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Parkinson's Disease With Cognitive ImpairmentNCT03879551

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

A study testing repetitive Transcranial Magnetic Stimulation in people with Parkinson's Disease With Cognitive Impairment, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years
What is being tested?
repetitive Transcranial Magnetic Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteEgypt
Study dates
15 Mar 2019to 15 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University

    Asyut, 11517

Other trials in Egypt

About this study

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

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.

Read the detailed description

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.

Being tested
repetitive Transcranial Magnetic Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • repetitive Transcranial Magnetic StimulationDevice

    Also called rTMS

    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.

Study groups in NCT03879551
Study groupRoleWhat they receive
Real rTMSActive comparatorReal 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.
Receives: Device: repetitive Transcranial Magnetic Stimulation
Sham rTMSSham comparatorSham 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.
Receives: Device: repetitive Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: three months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 10 days

Secondary outcomes (2)

  1. 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)

    Measured: 3 months

  2. changes in cortical excitability

    changes in cortical excitability (baseline, post treatment)

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start15 Mar 2019
  3. Primary completion15 Jun 2019
  4. Study completion15 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03879551
Sponsor's protocol ID
rTMS and cognition in PD
Status last verified
Jul 2020
First submitted
14 Mar 2019
Last updated
21 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 12633150

  • 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.

    PubMed 21487730

  • 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.

    PubMed 22806065

  • 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.

    PubMed 20437539

  • 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.

    PubMed 31815705

Questions about this trial

What is this clinical trial studying?

A study testing repetitive Transcranial Magnetic Stimulation in people with Parkinson's Disease With Cognitive Impairment, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in Mini Mental State Examination (MMSE) (time frame: three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879551, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.

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