TAME-PD - Physical Therapy, Atomoxetine And, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: a Single Center, Randomized Pilot Study

Who is this study for? Adult patients with Parkinson's Disease
What treatments are being studied? Methylphenidate
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Gait and balance problems are a significant source of disability in patients with Parkinson disease. Physical therapy remains one of the main treatments. On the other hand some medications, such as methyphenidate and atomoxetine, have been tried with promising results. The outcomes in gait and balance in Parkinson disease after a combination of physical therapy and the medications mentioned above have not been explored yet. The investigators want to evaluate whether the addition of medication, either low dose of methylphenidate or atomoxetine, to physical therapy will achieve improvement in gait and balance in Parkinson disease more than physical therapy alone. The investigators propose a pilot, single center, rater blind, prospective randomized trial. 2-arm-parallel group, intention-to-treat analysis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Jennifer Mule, B.S. Biology
mulej@ccf.org
216 444 1134
Backup
Jennifer Mule, B.S. Biology
mulej@ccf.org
Time Frame
Start Date: 2016-12
Estimated Completion Date: 2028-12
Participants
Target number of participants: 42
Treatments
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.
Active_comparator: Physical Therapy plus Methylphenidate
Methylphenidate 20 mg daily in combination with PT
Active_comparator: Physical Therapy plus Atomoxetine
Atomoxetine 10 mg daily in combination with PT or PT alone.
Authors
Shnehal Patel
Sponsors
Leads: Hubert Fernandez

This content was sourced from clinicaltrials.gov