Parkinson DiseaseATS-PIGDNCT05397340
Asymmetric Targeted DBS for PD With PIGD
A study testing Deep brain stimulation in people with Parkinson Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 3 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of idiopathic Parkinson's disease
- postural instability/gait difficulty (PIGD) phenotypes in both off- and on-medication condition
Who cannot join
- Atypical parkinsonism
- History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with intracranial surgery
- Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
- Presence of anatomical abnormalities in the target region
- Clinically significant medical history that would increase pre-/post-operative complications
- Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: 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
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.
Read the detailed description
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 ratioin 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.
- Conditions
- Parkinson Disease
- Being tested
- Deep brain stimulation
- Keywords
- postural instability/gait difficulty, deep brain stimulation, subthalamic nucleus, globus pallidus internus
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
active DBS with optimal stimulating parameters
| Study group | Role | What they receive |
|---|---|---|
| L-GPi/R-STN | Experimental | Participants randomized in this arm will receive L-GPi/R-STN stimulation for 1 year. Receives: Device: Deep brain stimulation |
| Bi-STN | Active comparator | Participants randomized in this arm will receive bilateral STN stimulation for 1 year. Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months
In the off-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms).
Measured: Baseline and 12 months
Change from Baseline in balance ability on the Berg Balance Scale (BBS) at 12 months
In the off-medication condition, the scores could range from 0 (severe balance problem) to 56 (no balance problem).
Measured: Baseline and 12 months
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 12 months
in the off-medication condition
Measured: Baseline and 12 months
Secondary outcomes (21)
Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months
In the on-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms).
Measured: Baseline and 12 months
Change from Baseline in balance ability on the Berg Balance Scale (BBS) at 12 months
In the on-medication condition, the scores could range from 0 (severe balance problem) to 56 (no balance problem).
Measured: Baseline and 12 months
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 12 months
in the on-medication condition
Measured: Baseline and 12 months
Change from Baseline in completion time on the Timed Up and Go test at 12 months
in the off-medication condition
Measured: Baseline and 12 months
Change from Baseline in completion time on the Timed Up and Go test at 6 months
in the off-medication condition
Measured: Baseline and 6 months
Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months
In the off-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms).
Measured: Baseline and 6 months
Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 12 months
The scores could range from 0 (no balance confidence) to 100 (good balance confidence).
Measured: Baseline and 12 months
Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 12 months
The scores could range from 0 (no freezing of gait) to 28 (severe freezing of gait).
Measured: Baseline and 12 months
Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 12 months
The scores could range from 0 (no dysphagia) to 44.5 (severe dysphagia).
Measured: Baseline and 12 months
Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 12 months
The scores could range from 0 (no gait impairment) to 64 (severe gait impairment).
Measured: Baseline and 12 months
Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 12 months
Measured: Baseline and 12 months
Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 6 months
Measured: Baseline and 6 months
Change from Baseline in maximal phonatory time at 12 months
Measured: Baseline and 12 months
Change from Baseline in maximal phonatory time at 6 months
Measured: Baseline and 6 months
Change from Baseline in dysphonia severity index (DSI) at 12 months
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.
Measured: Baseline and 12 months
Change from Baseline in dysphonia severity index (DSI) at 6 months
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.
Measured: Baseline and 6 months
Change from Baseline in cognition on the Montreal Cognitive Assessment at 12 months
The scores could range from 0 (severe cognition impairment) to 30 (no cognition impairment).
Measured: Baseline and 12 months
Change from Baseline in cognition on the Montreal Cognitive Assessment at 6 months
The scores could range from 0 (severe cognition impairment) to 30 (no cognition impairment).
Measured: Baseline and 6 months
Adverse events
Measured: up to 12 months after surgery
Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 6 months
In the off-medication condition, the scores could range from 0 (severe balance problem) to 56 (no balance problem).
Measured: Baseline and 6 months
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 6 months
in the off-medication condition
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Sep 2022
- Primary completion30 Oct 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dianyou Li, MD, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397340
- Sponsor's protocol ID
- Asym Stim-PIGD
- Acronym
- ATS-PIGD
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05397340
- Acronym / sponsor ID
- ATS-PIGD / Asym Stim-PIGD
- Conditions
- Parkinson Disease
- Keywords
- postural instability/gait difficulty, deep brain stimulation, subthalamic nucleus, globus pallidus internus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 ratioin 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-GPi/R-STN | Experimental | Device: Deep brain stimulationParticipants randomized in this arm will receive L-GPi/R-STN stimulation for 1 year. |
| Bi-STN | Active comparator | Device: Deep brain stimulationParticipants randomized in this arm will receive bilateral STN stimulation for 1 year. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of idiopathic Parkinson's disease
- postural instability/gait difficulty (PIGD) phenotypes in both off- and on-medication condition
Key exclusion criteria (6 listed)
- Atypical parkinsonism
- History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with intracranial surgery
- Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
- Presence of anatomical abnormalities in the target region
- Clinically significant medical history that would increase pre-/post-operative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulationactive DBS with optimal stimulating parameters | Device | Bi-STN, L-GPi/R-STN |
Primary outcome
Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months
Time frame: Baseline and 12 months
In the off-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms).
Change from Baseline in balance ability on the Berg Balance Scale (BBS) at 12 months
Time frame: Baseline and 12 months
In the off-medication condition, the scores could range from 0 (severe balance problem) to 56 (no balance problem).
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 12 months
Time frame: Baseline and 12 months
in the off-medication condition
21 secondary outcomes
Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months
Time frame: Baseline and 12 months
Change from Baseline in balance ability on the Berg Balance Scale (BBS) at 12 months
Time frame: Baseline and 12 months
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 12 months
Time frame: Baseline and 12 months
Change from Baseline in completion time on the Timed Up and Go test at 12 months
Time frame: Baseline and 12 months
Change from Baseline in completion time on the Timed Up and Go test at 6 months
Time frame: Baseline and 6 months
Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months
Time frame: Baseline and 6 months
Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 12 months
Time frame: Baseline and 12 months
Change from Baseline in freezing of gait on the New Freezing of Gait Questionnaire (NFOG-Q) at 12 months
Time frame: Baseline and 12 months
Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 12 months
Time frame: Baseline and 12 months
Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 12 months
Time frame: Baseline and 12 months
Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 12 months
Time frame: Baseline and 12 months
Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 6 months
Time frame: Baseline and 6 months
Change from Baseline in maximal phonatory time at 12 months
Time frame: Baseline and 12 months
Change from Baseline in maximal phonatory time at 6 months
Time frame: Baseline and 6 months
Change from Baseline in dysphonia severity index (DSI) at 12 months
Time frame: Baseline and 12 months
Change from Baseline in dysphonia severity index (DSI) at 6 months
Time frame: Baseline and 6 months
Change from Baseline in cognition on the Montreal Cognitive Assessment at 12 months
Time frame: Baseline and 12 months
Change from Baseline in cognition on the Montreal Cognitive Assessment at 6 months
Time frame: Baseline and 6 months
Adverse events
Time frame: up to 12 months after surgery
Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 6 months
Time frame: Baseline and 6 months
Change from Baseline in the number of freezing episodes on the Timed Up and Go test at 6 months
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dianyou Li, MD, PhD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Parkinson Disease, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 12 months (time frame: Baseline and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.