Parkinson's DiseaseNCT02875041
Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease
A study testing Transcranial Magnetic Stimulation (TMS) and MAGSTIM Rapid2 in people with Parkinson's Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a feasibility and exploratory pilot study of adjuvant transcranial magnetic stimulation (TMS) to physical therapy (PT) for locomotion and balance rehabilitation in Parkinson's disease patients. Read more about this study
- Who is it for?
- Ages 35 to 89 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) and MAGSTIM Rapid2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 2 May 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PD confirmed by a neurologist with expertise in movement disorders;
- Hoehn and Yahr stage 2 to 4;
- On L-Dopa and/or Dopamine Agonist daily treatment regimen;
- 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 months;
- Posture, locomotion and balance deficits requiring at least 10 sessions of PT.
Who cannot join
- History of seizure disorder, including febrile seizures, fainting spells or syncope of unknown cause(s);
- Neurological disorder other than PD including stroke (mild-to-moderate micro vascular disease is allowed), traumatic brain injury, brain tumors, hydrocephalus;
- Major or unstable medical illness;
- Pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed);
- Untreated depression; or Beck Depression Inventory (BDI)>22
- Taking any of the following medications within the four weeks prior to the start of the study: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, bupropion, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, and theophylline;
- History of moderate or severe dementia, or history of Mini Mental State Examination (MMSE) <20 or Montreal Cognitive Assessment (MoCA) <22;
- Physical therapy treatment contraindications as determined by physiotherapist.
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
Official title: Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease: A Feasibility and Pilot Study (Locom-TMS)
This is a feasibility and exploratory pilot study of adjuvant transcranial magnetic stimulation (TMS) to physical therapy (PT) for locomotion and balance rehabilitation in Parkinson's disease patients.
Read the detailed description
The primary outcomes will be feasibility of pairing 10 PT training sessions for PB\&G with rTMS therapy immediately following PT treatment session. Secondary outcomes will be exploratory, documenting differential clinical effects of two 'active' rTMS compared to 'sham' rTMS, to investigate ability to improve motor and functional recovery outcomes. Outcome measures will be a combination of assessments regularly conducted during PT treatment sessions validated in people with PD (these will doubly serve as our study measures) and several PD oriented outcomes.
- Conditions
- Parkinson's Disease
- Being tested
- Transcranial Magnetic Stimulation (TMS), MAGSTIM Rapid2
- Keywords
- rehabilitation, balance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
MAGSTIM Rapid2Device
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy | Experimental | TMS is a non-invasive device that employs the use of a magnet on the scalp to measure and potentially modulate cortical excitability. The use of TMS for Parkinson's treatment is experimental. Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| MAGSTIM Rapid2 Therapy System | Active comparator | MAGSTIM Rapid2 Therapy System has been FDA cleared for the treatment of refractory depression. Receives: Device: MAGSTIM Rapid2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Balance Evaluation Systems Test
(Mini-BESTest): This is a clinical balance assessment tool that asses dynamic balance through 14 items. It requires 10-15 minutes to be administered. Physical therapists at Rusk use this scale during their normal evaluative sessions.
Measured: 15 Minutes
Five times sit to stand (5XSST)
This is a measure of functional lower limb muscle strength and may be useful in quantifying functional change of transitional movements. Physical therapists use this scale during their normal evaluative sessions. We will use those data collected for our outcome purposes. It requires < 5 minutes to be administered. It is highly recommended and validated in PD by Parkinson's task force PD EDGE.
Measured: 5 Minutes
Timed up and go (TUG):
Assess walking speed in meters per second over a short duration. Time is measured as subject walks a set distance. Physical therapists use this scale during their normal evaluative sessions.
Measured: 3 Minutes
Unified Parkinson's Disease Rating Scale (UPDRS)
The UPDRS is a Parkinson's rating scale which includes evaluations of mentation, behavior, mood, and activities of daily life as well as a clinician scored evaluation to assess motor symptoms of Parkinson's disease.
Measured: 15 Minutes
Clinical Global Impression Scale-Severity and Improvement (CGI-S and CGI-I
CGI was designed to provide a brief stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. Its use has expanded to assess prior to and after any intervention. It takes less than a minute to administer by an experienced rater and it is a great tool to track clinical progress across time.
Measured: 15 Minutes
Parkinson's disease questionnaire-39 (PDQ-39)
Self-report questionnaire that assess PD-specific health related quality over the last month. It assessed how often patients experience difficulties across 8 quality of life dimensions and asses impact of PD on specific dimensions of functioning and well-being. It has become the most frequently used disease-specific measure of health status. It takes 10-20 minutes to be administered.
Measured: 20 Minutes
New Freezing of Gait Questionnaire (NFOG-Q)
This questionnaire will ask questions about symptoms of gait freezing (not being able to move). The NFOG-Q is a reliable tool to detect and evaluate the impact and severity of FOG in PD.
Measured: 20 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion2 May 2018
- Study completion2 May 2018
Why it stopped: Study required back-to-back physical therapy (PT) and TMS Experimental sessions; as our practice move to another building, away from PT
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milton Biagioni, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875041
- Sponsor's protocol ID
- 16-00966
- Status last verified
- May 2019
- First submitted
- 11 Aug 2016
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease: A Feasibility and Pilot Study (Locom-TMS)
- ClinicalTrials.gov ID
- NCT02875041
- Acronym / sponsor ID
- 16-00966
- Conditions
- Parkinson's Disease
- Keywords
- rehabilitation, balance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study required back-to-back physical therapy (PT) and TMS Experimental sessions; as our practice move to another building, away from PT
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 23 Aug 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 pilot study of adjuvant transcranial magnetic stimulation (TMS) to physical therapy (PT) for locomotion and balance rehabilitation in Parkinson's disease patients.
Detailed description
The primary outcomes will be feasibility of pairing 10 PT training sessions for PB\&G with rTMS therapy immediately following PT treatment session. Secondary outcomes will be exploratory, documenting differential clinical effects of two 'active' rTMS compared to 'sham' rTMS, to investigate ability to improve motor and functional recovery outcomes. Outcome measures will be a combination of assessments regularly conducted during PT treatment sessions validated in people with PD (these will doubly serve as our study measures) and several PD oriented outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy | Experimental | Device: Transcranial Magnetic Stimulation (TMS)TMS is a non-invasive device that employs the use of a magnet on the scalp to measure and potentially modulate cortical excitability. The use of TMS for Parkinson's treatment is experimental. |
| MAGSTIM Rapid2 Therapy System | Active comparator | Device: MAGSTIM Rapid2MAGSTIM Rapid2 Therapy System has been FDA cleared for the treatment of refractory depression. |
Who may qualify
- Ages
- 35 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of PD confirmed by a neurologist with expertise in movement disorders;
- Hoehn and Yahr stage 2 to 4;
- On L-Dopa and/or Dopamine Agonist daily treatment regimen;
- 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 months;
- Posture, locomotion and balance deficits requiring at least 10 sessions of PT.
Key exclusion criteria (8 listed)
- History of seizure disorder, including febrile seizures, fainting spells or syncope of unknown cause(s);
- Neurological disorder other than PD including stroke (mild-to-moderate micro vascular disease is allowed), traumatic brain injury, brain tumors, hydrocephalus;
- Major or unstable medical illness;
- Pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed);
- Untreated depression; or Beck Depression Inventory (BDI)>22
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Device | Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy |
| MAGSTIM Rapid2 | Device | MAGSTIM Rapid2 Therapy System |
Primary outcome
Mini Balance Evaluation Systems Test
Time frame: 15 Minutes
(Mini-BESTest): This is a clinical balance assessment tool that asses dynamic balance through 14 items. It requires 10-15 minutes to be administered. Physical therapists at Rusk use this scale during their normal evaluative sessions.
Five times sit to stand (5XSST)
Time frame: 5 Minutes
This is a measure of functional lower limb muscle strength and may be useful in quantifying functional change of transitional movements. Physical therapists use this scale during their normal evaluative sessions. We will use those data collected for our outcome purposes. It requires < 5 minutes to be administered. It is highly recommended and validated in PD by Parkinson's task force PD EDGE.
Timed up and go (TUG):
Time frame: 3 Minutes
Assess walking speed in meters per second over a short duration. Time is measured as subject walks a set distance. Physical therapists use this scale during their normal evaluative sessions.
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 15 Minutes
The UPDRS is a Parkinson's rating scale which includes evaluations of mentation, behavior, mood, and activities of daily life as well as a clinician scored evaluation to assess motor symptoms of Parkinson's disease.
Clinical Global Impression Scale-Severity and Improvement (CGI-S and CGI-I
Time frame: 15 Minutes
CGI was designed to provide a brief stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. Its use has expanded to assess prior to and after any intervention. It takes less than a minute to administer by an experienced rater and it is a great tool to track clinical progress across time.
Parkinson's disease questionnaire-39 (PDQ-39)
Time frame: 20 Minutes
Self-report questionnaire that assess PD-specific health related quality over the last month. It assessed how often patients experience difficulties across 8 quality of life dimensions and asses impact of PD on specific dimensions of functioning and well-being. It has become the most frequently used disease-specific measure of health status. It takes 10-20 minutes to be administered.
New Freezing of Gait Questionnaire (NFOG-Q)
Time frame: 20 Minutes
This questionnaire will ask questions about symptoms of gait freezing (not being able to move). The NFOG-Q is a reliable tool to detect and evaluate the impact and severity of FOG in PD.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 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 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 Transcranial Magnetic Stimulation (TMS) and MAGSTIM Rapid2 in people with Parkinson's 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 17 May 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 was withdrawn before enrolling participants, so there are no results.
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?
Mini Balance Evaluation Systems Test (time frame: 15 Minutes). The study lists 7 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 17 May 2019.