← Back to Search

Physical Therapy + Medication for Parkinson's Disease (TAME-PD Trial)

Phase < 1

Recruiting

Led By Shnehal Patel

Research Sponsored by Hubert Fernandez

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Punctuation of 5 in Hoehn and Yard modified scale: 'Wheelchair bound or bedridden unless aided'.

Presence of signs and symptoms suggestive of atypical parkinsonism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare physical therapy alone to physical therapy plus medication (either low dose methylphenidate or atomoxetine) to see if the addition of medication leads to more improvement in gait and balance in patients with Parkinson disease.

Who is the study for?

This trial is for Parkinson's disease patients with significant gait and balance issues, despite stable dopaminergic therapy. They must score ≥2 on the UPDRS item for walking impairment. Exclusions include severe mental health issues, epilepsy, heart problems, glaucoma, liver disease, allergies to study drugs, wheelchair dependence or bedridden state without help.

What is being tested?

The TAME-PD trial is testing if adding low doses of either methylphenidate or atomoxetine to physical therapy can improve gait and balance in Parkinson's patients more than physical therapy alone. It's a pilot study where participants are randomly assigned to one of two groups in a blinded fashion.

What are the potential side effects?

Potential side effects from methylphenidate may include nervousness, trouble sleeping and increased blood pressure. Atomoxetine might cause dry mouth, nausea or fatigue. Physical therapy generally has minimal risks but could sometimes result in muscle soreness.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need help to move from a wheelchair or bed.

Select...

I show signs of unusual Parkinson-like symptoms.

Select...

I don't have severe mental health issues, epilepsy, hyperthyroidism, glaucoma, irregular heartbeat, Tourette syndrome, liver disease, or allergies to specific ADHD medications.

Select...

I cannot undergo physical therapy due to health reasons.