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Parkinson's DiseasePD-MCI-TMSNCT03243214

Effect of Transcranial Magnetic Stimulation on Cognition and Neural Changes in Parkinson's Disease

A study testing TMS in people with Parkinson's Disease and Mild Cognitive Impairment, run by University of Calgary at 1 site in Canada.

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

Parkinson's disease (PD) affects more than 100,000 Canadians and results in symptoms affecting both motor and cognitive (thinking and memory) functions. Parkinson's disease with Mild Cognitive Impairment (MCI) frequently results in development of dementia for which few treatment options exist. Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
TMS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteCanada
Study dates
24 Oct 2016to 14 Feb 2020
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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of idiopathic Parkinson's disease any stage
  • Mild Cognitive Behaviour confirmed through neuropsychological assessment
  • MRI Compatibility

Who cannot join

  • Alcohol-dependency
  • Severe psychiatric disorder, neurological disorder, epilepsy or stroke
  • General anaesthesia in the past six months
  • History of cerebrovascular disorders
  • Colour-blindness

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Calgary, Department of Clinical Neurosciences

    Calgary, Alberta, T2N 4N1

Other trials in Canada

About this study

Official title: Effect of Excitatory Theta-Burst Transcranial Magnetic Stimulation on Cognition in Patients With Both Parkinson's Disease and Mild Cognitive Impairment and Analysis of Functional and Structural Brain Changes After Stimulation

Parkinson's disease (PD) affects more than 100,000 Canadians and results in symptoms affecting both motor and cognitive (thinking and memory) functions. Parkinson's disease with Mild Cognitive Impairment (MCI) frequently results in development of dementia for which few treatment options exist. Transcranial Magnetic Stimulation (TMS) is used to alter activity in the outer regions of the brain and has been shown in previous studies to increase cognitive performance in patients with different disorders. This study will investigate the effectiveness of TMS as a clinical treatment for the cognitive deficits associated with Parkinson's disease. 64 male and female participants between the ages of 50 and 90 will attend eight study visits over a period of 63 to 66 days. This study is a double-blind randomized clinical trial meaning the participant will be assigned by chance to either the TMS-treatment group or the Sham-treatment group. Additionally, a combination of memory and thinking tests and Magnetic Resonance Imaging (MRI) will be used to see if there are structural and functional changes within the brain. Genotyping and blood analysis before and after treatment for different biomarkers will also be performed and these data will be compared to the TMS data. Initially, this research will increase knowledge about the effects of TMS on various brain regions. Ultimately, we will be able to determine if TMS can be used as a complementary therapy for PD to improve cognitive performance and to reduce progression into dementia.

Read the detailed description

Visit 1:

Informed Consent Neuropsychological Battery

Visit 2: (1-2 days later) Blood Draw Neuropsychiatric Assessment Questionnaires Companion Questionnaire to take home UPDRS

Visit 3: (up to a week after visit 2) MRI Scan while performing Executive Task

Visit 4: (1-3 days after visit 3) TMS- or Sham-Treatment (two sessions , 20 min each, 1 hour apart)

Visit 5: (2-3 days after visit 4) Same as Visit 4

Visit 6: (2-3 days after visit 5) Same as Visit 4

Visit 7: (1 day after visit 6) Neuropsychological Battery UPDRS

Visit 8: (1 day after visit 7) MRI Scan while performing Executive Task Blood Draw

Visit 9: (1 month after visit 6) Neuropsychological Battery UPDRS

Being tested
TMS, Sham-TMS
Keywords
Transcranial Magnetic Stimulation
Medical subject headings
Parkinson Disease, Cognitive Dysfunction

What participants receive

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

  • TMSDevice

    Also called Magstim

    Real or Sham TMS will be given to the PD-MCI patient

  • Sham-TMSDevice

    Real or Sham TMS will be given to the PD-MCI patient

Study groups in NCT03243214
Study groupRoleWhat they receive
PD-MCI, TMSActive comparatorThe patient is treated with TMS stimulation according to protocol with an active coil.
Receives: Device: TMS
PD-MCI, Sham-TMSSham comparatorThe patient is treated with Sham-TMS stimulation according to protocol with an inactive coil.
Receives: Device: Sham-TMS

What is being measured

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

  1. TMS stimulation applied to the left DLPFC has a quantifiable effect on cognition

    Changes in one or more of the five assessed brain domains at baseline and one day after stimulation will be measured by comparing the scores for the different neuropsychological tests.

    The same neuropsychological assessment one month after TMS stimulation will show, if possible changes from one day after are longer lasting and can still be seen.

    Measured: Neuropsychological Assessments: Baseline, one day after and one month after TMS stimulation

Secondary outcomes (4)

  1. Change in structural grey and white matter in the brain at baseline compared to after TMS stimulation

    MRI analysis will measure any changes in cortical thickness (mm) or other structural changes in the brain after TMS or Sham-TMS stimulation

    Measured: MRI: Baseline and two days after TMS stimulation

  2. Change in executive functioning measured as BOLD fMRI sequence

    The executive task, Wisconsin Card Sorting Task, will be performed in the scanner to measure the level of activation in the basal ganglia and the prefrontal cortex via BOLD functional MRI sequence to see changes after TMS stimulation compared to baseline.

    Measured: MRI: Baseline and two days after TMS stimulation

  3. Change in levels of biomarkers of interest (alpha-synuclein and BDNF) in serum after TMS stimulation compared to baseline.

    Measure the concentration of alpha-synuclein and BDNF in serum at baseline and after TMS stimulation with the Meso Scale Discovery method. These assays are highly developed ELISA assays using electrochemiluminescence.

    Measured: Blood draws: Baseline and two days after TMS stimulation

  4. Genotyping

    Analyze DNA for following genes: COMT, DAT1, MAPT, ApoE, GBA, CHCRA4, SNCA, BDNF These genes of interest will be correlated to changes in the neuropsychological assessments.

    Measured: Blood draw for DNA analysis: Baseline

Timeline

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

  1. First posted8 Aug 2017
  2. Study start24 Oct 2016
  3. Primary completion14 Feb 2020
  4. Study completion14 Feb 2020

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
Sequential
Model description
This is a randomized double blind trial.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03243214
Sponsor's protocol ID
REB15-1689
Acronym
PD-MCI-TMS
Status last verified
Oct 2020
First submitted
2 Aug 2017
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lang S, Gan LS, Yoon EJ, Hanganu A, Kibreab M, Cheetham J, Hammer T, Kathol I, Sarna J, Martino D, Monchi O. Theta-Burst Stimulation for Cognitive Enhancement in Parkinson's Disease With Mild Cognitive Impairment: A Randomized, Double-Blind, Sham-Controlled Trial. Front Neurol. 2020 Dec 21;11:584374. doi: 10.3389/fneur.2020.584374. eCollection 2020.

    PubMed 33408684

Questions about this trial

What is this clinical trial studying?

A study testing TMS in people with Parkinson's Disease and Mild Cognitive Impairment, run by University of Calgary at 1 site in Canada.

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 3 inclusion and 5 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 19 Oct 2020. 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 Canada. 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?

TMS stimulation applied to the left DLPFC has a quantifiable effect on cognition (time frame: Neuropsychological Assessments: Baseline, one day after and one month after TMS stimulation). 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 NCT03243214, which also lists 1 linked publication.

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 19 Oct 2020.

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