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

Not Applicable

Withdrawn

• Conditions: Parkinson's Disease
• Interventions: Device: MAGSTIM Rapid2; Device: Transcranial Magnetic Stimulation (TMS)

• Registration Number: NCT02875041
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-23
• Primary Completion: 2018-05-02
• Study Completion: 2018-05-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAGSTIM Rapid2 Therapy System	MAGSTIM Rapid2	MAGSTIM Rapid2 Therapy System has been FDA cleared for the treatment of refractory depression.
Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy	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.

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS)	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	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.
Mini Balance Evaluation Systems Test	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.
Parkinson's disease questionnaire-39 (PDQ-39)	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)	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.
Timed up and go (TUG):	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.
Five times sit to stand (5XSST)	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States