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

NCT ID: NCT02875041

Last Updated: 2019-05-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-05-02

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation (TMS)

Intervention Type: DEVICE

MAGSTIM Rapid2 Therapy System

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

Group Type: ACTIVE_COMPARATOR

MAGSTIM Rapid2

Intervention Type: DEVICE

Interventions

Transcranial Magnetic Stimulation (TMS)

Intervention Type: DEVICE

MAGSTIM Rapid2

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Milton Biagioni

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

16-00966

Identifier Type: -

Identifier Source: org_study_id