TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease (TAME-PD)
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ClinicalTrials.gov Identifier: NCT02879136 |
Recruitment Status :
Recruiting
First Posted : August 25, 2016
Last Update Posted : February 16, 2024
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Condition or disease | Intervention/treatment | Phase |
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Parkinson's Disease, Idiopathic | Drug: Methylphenidate Other: Physical Therapy Drug: Atomoxetine | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot Study |
Study Start Date : | December 2016 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2026 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Physical Therapy
Physical Therapy (PT) will consist of two weekly sessions over a 12 week period using the Mellen center protocol PT for PD.
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Other: Physical Therapy
All Patients will have standard of care PT used for PD patients
Other Name: PT |
Active Comparator: Physical Therapy plus Methylphenidate
Methylphenidate 20 mg daily in combination with PT
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Drug: Methylphenidate
Patient will be randomized to Methylphenidate
Other Name: Ritalin Other: Physical Therapy All Patients will have standard of care PT used for PD patients
Other Name: PT |
Active Comparator: Physical Therapy plus Atomoxetine
Atomoxetine 10 mg daily in combination with PT or PT alone.
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Other: Physical Therapy
All Patients will have standard of care PT used for PD patients
Other Name: PT Drug: Atomoxetine Patient will be randomized to Atomoxetine
Other Name: Straterra |
- Balance Evaluation [ Time Frame: 12 weeks ]Change in the balance evaluation systems test, MiniBest is standard gait analysis measure conducted by physical therapists.
- Change in gait [ Time Frame: 12 weeks ]Stride length and gait velocity measured using "GaitRite", which is a standard gait analysis measure conducted by physical therapists.
- Motor function [ Time Frame: 12 weeks ]UPDRS part III scale
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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with PD having significant balance or gait disorder with a score ≥2 in the Unified Parkinson Disease Rating Scale (UPDRS) 3.10 item 'independent walking but with substantial gait impairment; not related to off periods' occurring despite satisfactory motor control by dopaminergic therapy, with a medication regimen unlikely to change in the next 30 days.
Exclusion Criteria:
- Previous participation in PD-specific PT.
- Presence of signs and symptoms suggestive of atypical parkinsonism.
- Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases.
- Contraindication for physical therapy
- Comorbidities that contraindicate the use of the methylphenidate or atomoxetine: history of substance abuse, current severe anxiety, depression or psychosis, epilepsy, hyperthyroidism, glaucoma, cardiac arrhythmia, history of Tourette syndrome, hepatic disease, allergy to methylphenidate or atomoxetine.
- Concurrent use of MAO inhibitors, or use in the last two weeks.
- Previous deep brain stimulation procedure.
- Punctuation of 5 in Hoehn and Yard modified scale: 'Wheelchair bound or bedridden unless aided'.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879136
Contact: Shnehal Patel, MD | patels7@ccf.org | ||
Contact: Jennifer Mule | mulej@ccf.org |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Shnehal Patel, MD patels7@ccf.org | |
Contact: Jennifer Mule, BS mulej@ccf.org |
Principal Investigator: | Shnehal Patel | The Cleveland Clinic |
Responsible Party: | Hubert Fernandez, Principal Investigator, The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT02879136 |
Other Study ID Numbers: |
16-277 |
First Posted: | August 25, 2016 Key Record Dates |
Last Update Posted: | February 16, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Gait Balance PD |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Methylphenidate Atomoxetine Hydrochloride |
Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Adrenergic Uptake Inhibitors Adrenergic Agents |