Back to resultsNon-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
MAGSTIM Rapid2
Sponsored by
About this trial
This is an interventional other trial for Parkinson's Disease focused on measuring rehabilitation, balance
Eligibility Criteria
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy
MAGSTIM Rapid2 Therapy System
Arm Description
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 has been FDA cleared for the treatment of refractory depression.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02875041
Brief Title
Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease
Official Title
Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease: A Feasibility and Pilot Study (Locom-TMS)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study required back-to-back physical therapy (PT) and TMS Experimental sessions; as our practice move to another building, away from PT
Study Start Date
August 2016 (undefined)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
rehabilitation, balance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
MAGSTIM Rapid2 Therapy System
Arm Type
Active Comparator
Arm Description
MAGSTIM Rapid2 Therapy System has been FDA cleared for the treatment of refractory depression.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Type
Device
Intervention Name(s)
MAGSTIM Rapid2
Primary Outcome Measure Information:
Title
Mini Balance Evaluation Systems Test
Description
(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.
Time Frame
15 Minutes
Title
Five times sit to stand (5XSST)
Description
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.
Time Frame
5 Minutes
Title
Timed up and go (TUG):
Description
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.
Time Frame
3 Minutes
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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.
Time Frame
15 Minutes
Title
Clinical Global Impression Scale-Severity and Improvement (CGI-S and CGI-I
Description
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.
Time Frame
15 Minutes
Title
Parkinson's disease questionnaire-39 (PDQ-39)
Description
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.
Time Frame
20 Minutes
Title
New Freezing of Gait Questionnaire (NFOG-Q)
Description
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.
Time Frame
20 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton Biagioni
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease
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