Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease
Status: | Terminated |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 35 - 89 |
Updated: | 8/29/2018 |
Start Date: | August 2016 |
End Date: | May 2, 2018 |
Non-Invasive TMS Neuromodulation for Enduring Balance & Locomotion Restoration in Parkinson's Disease: A Feasibility and Pilot Study (Locom-TMS)
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.
stimulation (TMS) to physical therapy (PT) for locomotion and balance rehabilitation in
Parkinson's disease patients.
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.
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.
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.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Milton Biagioni, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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