Clinical trial NCT02875041: Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease
Official title: Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease: A Feasibility and Pilot Study (Locom-TMS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: rehabilitation
balance
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Mini Balance Evaluation Systems Test
timeFrame: 15 Minutes
measure: Five times sit to stand (5XSST)
timeFrame: 5 Minutes
measure: Timed up and go (TUG):
timeFrame: 3 Minutes
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 15 Minutes
measure: Clinical Global Impression Scale-Severity and Improvement (CGI-S and CGI-I
timeFrame: 15 Minutes
measure: Parkinson's disease questionnaire-39 (PDQ-39)
timeFrame: 20 Minutes
measure: New Freezing of Gait Questionnaire (NFOG-Q)
timeFrame: 20 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Milton Biagioni
role: PRINCIPAL_INVESTIGATOR
References: