Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease

May 15, 2019 updated by: NYU Langone Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy
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.
Device: Transcranial Magnetic Stimulation (TMS)
Active Comparator: MAGSTIM Rapid2 Therapy System
MAGSTIM Rapid2 Therapy System has been FDA cleared for the treatment of refractory depression.
Device: MAGSTIM Rapid2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
15 Minutes
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.
5 Minutes
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.
3 Minutes
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.
15 Minutes
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.
15 Minutes
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.
20 Minutes
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.
20 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Milton Biagioni, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-00966

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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