The purpose of this study is to compare the effectiveness of the deep brain stimulation
of asymmetric targets [subthalamic nucleus (STN) in the right hemisphere while globus
pallidus interna (GPi) in the left] versus the bilateral STN for the treatment of
Parkinson's disease (PD) with postural instability/gait difficulty (PIGD) in a
randomized, double-blinded manner.

Asymmetric Targeted DBS for PD With PIGD

Parkinson Disease

This is a double-blinded, randomized, controlled trial aiming at comparing the efficacy
of asymmetric targets and bilateral STN DBS in treating PD with PIGD.

After being informed about the study and potential risks, enrolled patients giving
written informed consent will be screened to determine eligibility for study entry.
Patients who meet the eligibility requirements will be randomized into two groups in a
1:1 ratio using a minimization randomization method in a double-blinded manner, and later
undergo bilateral DBS surgery. One group of patients will receive stimulation of left GPi
and right STN, while the other will receive STN stimulation bilaterally. The follow-up
period will be one year, with corresponding clinical assessments completed at six months
and one year postoperatively.

Deep brain stimulation

Deep Brain Stimulation of Asymmetric Targets Versus Bilateral Subthalamic Nucleus (STN) for Parkinson's Disease With Postural Instability/Gait Difficulty: a Prospective, Randomized, Double-blinded Trial

In the off-medication condition, scores could range from 0 (no movement symptoms) to 72
(severe movement symptoms).

In the off-medication condition, the scores could range from 0 (severe balance problem)
to 56 (no balance problem).

The scores could range from 0 (no balance confidence) to 100 (good balance confidence).

The scores could range from 0 (no freezing of gait) to 28 (severe freezing of gait).

The scores could range from 0 (no dysphagia) to 44.5 (severe dysphagia).

The scores could range from 0 (no gait impairment) to 64 (severe gait impairment).

DSI=0.13 x MPT + 0.0053 x F-High - 0.26 x I-Low - 1.18 x Jitter (%) + 12.4. The DSI for
perceptually normal voices equals +5 and for severely dysphonic voices -5. The more
negative the patient's index is, the worse is his or her vocal quality.

The scores could range from 0 (severe cognition impairment) to 30 (no cognition
impairment).

Participants randomized in this arm will receive L-GPi/R-STN stimulation for 1 year.

Participants randomized in this arm will receive bilateral STN stimulation for 1 year.

Asymmetric Targeted DBS for PD With PIGD

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status