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

NYU Langone Health

Status: Withdrawn

Conditions: Parkinson's Disease

Treatments: Device: MAGSTIM Rapid2; Device: Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02875041

16-00966

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy

Experimental group

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.

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

MAGSTIM Rapid2 Therapy System

Active Comparator group

Description:

MAGSTIM Rapid2 Therapy System has been FDA cleared for the treatment of refractory depression.

Treatment:

Device: MAGSTIM Rapid2