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

Q: What is the aggregate populace of participants taking part in this research?

Affirmative. The medical trial is actively looking for participants, as evidenced by the information on clinicaltrials.gov which was last updated February 15th 2022 - shortly after being posted December 1st 2016. 42 patients are sought from a single location to take part in this study.

Q: Who has the necessary qualifications for taking part in this research project?

This medical trial is seeking 42 individuals suffering from <a href="https://www.withpower.com/clinical-trials/parkinson&#x27;s-disease">Parkinson's disease</a>, aged 18-90. To be considered for enrolment, patients must have a score of 2 or higher in the UPDRS 3.10 item 'independent walking but with substantial gait impairment; not related to off periods'. Furthermore, their dopaminergic treatment must remain consistent during the next month.

Q: Are there enrollment opportunities for this clinical exploration at present?

Per the details available on clinicaltrials.gov, this investigation is presently enrolling participants in its research cohort. The trial was initially published online on December 1st 2016 and recently updated February 15th 2022.

Q: What have prior research efforts divulged about the combination of Physical Therapy and Atomoxetine?

At present, 4 Phase 3 trials investigating the combination of Physical Therapy and Atomoxetine are ongoing. There is a concentration of studies centered in Houston, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> but altogether there are 126 locations running this clinical research.

Q: Are individuals over 85 years of age being accepted into this research program?

This clinical trial has established that 18 is the minimum age of participation, while 90 years old represent the cut-off for qualifications.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

TAME-PD Trial 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.Check my eligibility

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.See study design

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.

TAME-PD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Balance Evaluation

Secondary outcome measures

Change in gait

Other outcome measures

Motor function

TAME-PD Trial Design

3Treatment groups

Active Control

Group I: Physical TherapyActive Control1 Intervention

Physical Therapy (PT) will consist of two weekly sessions over a 12 week period using the Mellen center protocol PT for PD.

Group II: Physical Therapy plus MethylphenidateActive Control2 Interventions

Methylphenidate 20 mg daily in combination with PT

Group III: Physical Therapy plus AtomoxetineActive Control2 Interventions

Atomoxetine 10 mg daily in combination with PT or PT alone.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hubert FernandezLead Sponsor

Shnehal PatelPrincipal InvestigatorThe Cleveland Clinic

Media Library

Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02879136 — Phase < 1

Parkinson's Disease Research Study Groups: Physical Therapy, Physical Therapy plus Methylphenidate, Physical Therapy plus Atomoxetine

Parkinson's Disease Clinical Trial 2023: Physical Therapy Highlights & Side Effects. Trial Name: NCT02879136 — Phase < 1

Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02879136 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate populace of participants taking part in this research?

"Affirmative. The medical trial is actively looking for participants, as evidenced by the information on clinicaltrials.gov which was last updated February 15th 2022 - shortly after being posted December 1st 2016. 42 patients are sought from a single location to take part in this study."

Answered by AI

Who has the necessary qualifications for taking part in this research project?

"This medical trial is seeking 42 individuals suffering from Parkinson's disease, aged 18-90. To be considered for enrolment, patients must have a score of 2 or higher in the UPDRS 3.10 item 'independent walking but with substantial gait impairment; not related to off periods'. Furthermore, their dopaminergic treatment must remain consistent during the next month."

Answered by AI

Are there enrollment opportunities for this clinical exploration at present?

"Per the details available on clinicaltrials.gov, this investigation is presently enrolling participants in its research cohort. The trial was initially published online on December 1st 2016 and recently updated February 15th 2022."

Answered by AI

What have prior research efforts divulged about the combination of Physical Therapy and Atomoxetine?

"At present, 4 Phase 3 trials investigating the combination of Physical Therapy and Atomoxetine are ongoing. There is a concentration of studies centered in Houston, Texas but altogether there are 126 locations running this clinical research."

Answered by AI