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

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• Status: Withdrawn
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation (TMS); Device: MAGSTIM Rapid2

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	20 Minutes

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Milton Biagioni, New York University Medical School

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): May 2, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: rehabilitation; balance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID 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