Parkinson DiseaseNCT02741765
Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease
A study testing Real rTMS and Supervised aerobic exercise in people with Parkinson Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a feasibility and exploratory study consisting of two parts: first, a cross-sectional (one-time) biomarker measurement comparing BDNF-TrkB (Brain-derived neurotrophic factor (BDNF) and its receptor, TrkB,) signaling and cortical plasticity in patients diagnosed with Parkinson's Disease (PD) vs. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Real rTMS and Supervised aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 26 Jan 2018
- 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 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of PD according to the UK Brain Bank Criteria, confirmed by a neurologist with expertise in movement disorders;
- Hoehn and Yahr stage II to III;
- On a stable medication regimen since at least 2 weeks prior the enrolment in the study and, in the view of the treating neurologist, unlikely to require medication adjustments in the following 3-6 months.
- Male or Female; aged 35-85
Who cannot join
- History of seizure disorder, including febrile seizures;
- Neurological disorder including PD, stroke, traumatic brain injury, fainting spells or syncope of unknown cause(s);
- Major or unstable medical illness;
- Pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed);
- Untreated depression, or score of >20 on Beck Depression Inventory II;
- Taking any of the following medications within the six weeks prior to the start of the study: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, theophylline, calcium channel blockers, beta blockers, tadalafil, vardenafil, avanafil, and sildenafil;
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- Diagnosis of dementia, or Montreal Cognitive Assessment (MoCA) <20;
- Any clinically significant abnormality on vital signs
- Cardiopulmonary limitations: untreated high blood pressure, history of heart insufficiency (class II-III), coronary vascular disease, angina, arrhythmia, dyspnea on exertion and asthma
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This is a feasibility and exploratory study consisting of two parts: first, a cross-sectional (one-time) biomarker measurement comparing BDNF-TrkB (Brain-derived neurotrophic factor (BDNF) and its receptor, TrkB,) signaling and cortical plasticity in patients diagnosed with Parkinson's Disease (PD) vs. healthy controls matched by age. Second, a prospective, randomized, double blind trial of Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy System (TMS) (real or Sham) and aerobic exercise. This exploratory feasibility study will look at BDNF-TrkB signaling and cortical plasticity.
Read the detailed description
Twenty-four PD patients (n=24) will be randomly assigned to receive one of two interventions for a duration of two weeks. In Group 1, subjects will participate in daily sessions of sham-rTMS followed by supervised aerobic exercise (Sham rTMS+Aerobic); in Group 2, subjects will participate in a combination of rTMS and supervised aerobic exercise (Real rTMS+Aerobic). Serum BDNF-TrkB signaling in lymphocytes and TMS-based electrophysiological measures of LTP-like plasticity will be measured. A comparison of such measures in a group of patients with PD and in a group of age-matched controls (n=12) will be analyzed to establish the effect of the disease on indices of plasticity.
- Conditions
- Parkinson Disease
- Being tested
- Sham rTMS, Real rTMS, Supervised aerobic exercise
- Keywords
- Transcranial Magnetic Stimulation, Exercise, Brain Plasticity
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham rTMSBehavioural
Subjects will participate in daily sessions of sham-rTMS
Real rTMSOther
Subjects will participate in a combination of rTMS
Supervised aerobic exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Sham Group | Active comparator | Sham group will receive Sham rTMS+Aerobic Exercise Receives: Behavioral: Sham rTMS; Behavioral: Supervised aerobic exercise |
| Group 2: Real Group | Experimental | rTMS+Aerobic Exercise Receives: Other: Real rTMS; Behavioral: Supervised aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Enrollment Numbers
Measured: 2 Weeks
Number of enrolled subjects that remain in study
Measured: 2 Weeks
Secondary outcomes (10)
Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker)
A paired associative paradigm at 25 ms (TMS-PAS-25) to quantify cortical LTP in M1 motor cortex will be used. As well as a repetitive biphasic magnetic stimulator (Magstim Rapid2 stimulator -Magstim Co., Whitland, U.K.) with a "Figure of eight" coil (outer diameters: 9 cm) and apply standard protocol for LTP-like measurements.
Measured: 2 Weeks
Measurements of lymphocytes
Measured: 2 Weeks
Measurements of TrkB
Measured: 2 Weeks
Measurements of serum BDNF
Measured: 2 Weeks
Timed Up and Go Test
Measured: 2 Weeks
Freezing of Gait Questionnaire (FOG-Q)
Measured: 2 Weeks
Parkinson's Disease Quality of Life (PDQ-39)
Measured: 2 Weeks
Parkinson's Disease Sleep Scale (PDSS)
Measured: 2 Weeks
Frontal Function Assessment (FAB)
Measured: 2 Weeks
LASA Physical Activity Questionnaire (LAPAQ)
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startNov 2015
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milton Biagioni, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741765
- Sponsor's protocol ID
- 15-00712
- Status last verified
- Jul 2019
- First submitted
- 31 Mar 2016
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02741765
- Acronym / sponsor ID
- 15-00712
- Conditions
- Parkinson Disease
- Keywords
- Transcranial Magnetic Stimulation, Exercise, Brain Plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility and exploratory study consisting of two parts: first, a cross-sectional (one-time) biomarker measurement comparing BDNF-TrkB (Brain-derived neurotrophic factor (BDNF) and its receptor, TrkB,) signaling and cortical plasticity in patients diagnosed with Parkinson's Disease (PD) vs. healthy controls matched by age. Second, a prospective, randomized, double blind trial of Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy System (TMS) (real or Sham) and aerobic exercise. This exploratory feasibility study will look at BDNF-TrkB signaling and cortical plasticity.
Detailed description
Twenty-four PD patients (n=24) will be randomly assigned to receive one of two interventions for a duration of two weeks. In Group 1, subjects will participate in daily sessions of sham-rTMS followed by supervised aerobic exercise (Sham rTMS+Aerobic); in Group 2, subjects will participate in a combination of rTMS and supervised aerobic exercise (Real rTMS+Aerobic). Serum BDNF-TrkB signaling in lymphocytes and TMS-based electrophysiological measures of LTP-like plasticity will be measured. A comparison of such measures in a group of patients with PD and in a group of age-matched controls (n=12) will be analyzed to establish the effect of the disease on indices of plasticity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Sham Group | Active comparator | Behavioral: Sham rTMS, Behavioral: Supervised aerobic exerciseSham group will receive Sham rTMS+Aerobic Exercise |
| Group 2: Real Group | Experimental | Other: Real rTMS, Behavioral: Supervised aerobic exerciserTMS+Aerobic Exercise |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PD according to the UK Brain Bank Criteria, confirmed by a neurologist with expertise in movement disorders;
- Hoehn and Yahr stage II to III;
- On a stable medication regimen since at least 2 weeks prior the enrolment in the study and, in the view of the treating neurologist, unlikely to require medication adjustments in the following 3-6 months.
- Male or Female; aged 35-85
Key exclusion criteria (9 listed)
- History of seizure disorder, including febrile seizures;
- Neurological disorder including PD, stroke, traumatic brain injury, fainting spells or syncope of unknown cause(s);
- Major or unstable medical illness;
- Pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed);
- Untreated depression, or score of >20 on Beck Depression Inventory II;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham rTMSSubjects will participate in daily sessions of sham-rTMS | Behavioural | Group 1: Sham Group |
| Real rTMSSubjects will participate in a combination of rTMS | Other | Group 2: Real Group |
| Supervised aerobic exercise | Behavioural | Group 1: Sham Group, Group 2: Real Group |
Primary outcome
Recruitment Enrollment Numbers
Time frame: 2 Weeks
Number of enrolled subjects that remain in study
Time frame: 2 Weeks
10 secondary outcomes
Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker)
Time frame: 2 Weeks
Measurements of lymphocytes
Time frame: 2 Weeks
Measurements of TrkB
Time frame: 2 Weeks
Measurements of serum BDNF
Time frame: 2 Weeks
Timed Up and Go Test
Time frame: 2 Weeks
Freezing of Gait Questionnaire (FOG-Q)
Time frame: 2 Weeks
Parkinson's Disease Quality of Life (PDQ-39)
Time frame: 2 Weeks
Parkinson's Disease Sleep Scale (PDSS)
Time frame: 2 Weeks
Frontal Function Assessment (FAB)
Time frame: 2 Weeks
LASA Physical Activity Questionnaire (LAPAQ)
Time frame: 2 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milton Biagioni, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real rTMS and Supervised aerobic exercise in people with Parkinson Disease, run by NYU Langone Health at 1 site in United States.
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 4 inclusion and 9 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 16 Jul 2019. 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 United States. 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. 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?
Recruitment Enrollment Numbers (time frame: 2 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.