Thoracic epidural spinal cord stimulation to reduce freezing of gait in advanced Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Investigators will place temporary, minimally invasive thoracic epidural stimulation electrodes and test different stimulation settings to see if gait stability and freezing episodes improve. The trial enrolls people aged 40–85 with primary Parkinson's disease for more than five years who have medication-refractory freezing of gait and no other secondary gait disorders. Outcomes will include measures of gait, freezing frequency, fall risk, and safety during and after temporary stimulation. The procedures are performed at a single center (National Taiwan University Hospital Hsin-Chu Branch) with exclusions for spinal canal stenosis, prior surgery or infection near the implantation site, atypical Parkinsonism, and spinal cord injury.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age:40-85 years old.
* Patients with primary Parkinson\'s disease who have been diagnosed by a movement disorder specialist for more than 5 years. Although they have a clear response to drugs, they have a frozen gait that cannot be controlled by drugs. Lower limb pain may be present with or without Parkinson\'s non-motor symptoms.
* No other secondary gait problems.

Exclusion Criteria:

* Atypical Parkinson's disease.
* Patients with spinal cord injuries.
* Medication-controlled frozen gait.
* It is expected that there are lesions near the implantation area causing spinal canal stenosis or myelopathy (can be ruled out by MRI).
* It is expected that the implantation area has undergone previous surgery or there is infection near the implantation area, which may affect the success rate of implantation or increase concerns about complications (such as severe extraspinal adhesion, or spinal cord damage in previous surgeries).
* People with abnormal coagulation function (such as hemophilia patients) or those who have been controlled by long-term use of antithrombotic drugs and cannot stop taking them in a short period of time.
* CDR (Clinical Dementia Rating Scale) ≧2. 8. Those who are allergic to developer.

Where it's running

• National Taiwan University Hospital Hsin-Chu Branch
  Hsinchu, Hsinchu City, Taiwan Recruiting

Study contacts

• Study coordinator: Kai-Hsiang Chen, M.D.
• Email: stanleychen1230@gmail.com
• Phone: +886-3-5326151

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.