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

NCT02875041 | Withdrawn FDA Device

• 1 other identifier: 16-00966
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

rehabilitation; balance

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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.

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.

Device: MAGSTIM Rapid2

Interventions

Transcranial Magnetic Stimulation (TMS) DEVICE

Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy

MAGSTIM Rapid2 DEVICE

MAGSTIM Rapid2 Therapy System

Eligibility Criteria

• Age: 35 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Milton Biagioni

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 23, 2016
• Study Start: August 1, 2016
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: May 17, 2019

Record last verified: 2019-05

Locations

US (1)