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Completed

NCT Number: NCT05397340

Asymmetric Targeted DBS for PD With PIGD

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of idiopathic Parkinson's disease
  • postural instability/gait difficulty (PIGD) phenotypes in both off- and on-medication condition

Exclusion criteria

  • 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

Treatment and study plan

Deep brain stimulation

Device

active DBS with optimal stimulating parameters

Primary outcomes

  1. 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).

  2. 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).

  3. 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

Secondary outcomes

  1. 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 on-medication condition, scores could range from 0 (no movement symptoms) to 72 (severe movement symptoms).

  2. Change from Baseline in balance ability on the Berg Balance Scale (BBS) at 12 months

    Time frame: Baseline and 12 months

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

  3. 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 on-medication condition

  4. Change from Baseline in completion time on the Timed Up and Go test at 12 months

    Time frame: Baseline and 12 months

    in the off-medication condition

  5. Change from Baseline in completion time on the Timed Up and Go test at 6 months

    Time frame: Baseline and 6 months

    in the off-medication condition

  6. 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

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

  7. Change from Baseline in balance confidence on the Activities-Specific Balance Confidence Scale (ABC) at 12 months

    Time frame: Baseline and 12 months

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

  8. 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

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

  9. Change from Baseline in dysphagia severity on the Swallowing Disturbance Questionnaire (SDQ) at 12 months

    Time frame: Baseline and 12 months

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

  10. Change from Baseline in gait impairment on the Gait and Fall Questionnaire (GFQ) at 12 months

    Time frame: Baseline and 12 months

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

  11. Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 12 months

    Time frame: Baseline and 12 months

  12. Change from Baseline in medication usage on the Levodopa Equivalent Daily Dose at 6 months

    Time frame: Baseline and 6 months

  13. Change from Baseline in maximal phonatory time at 12 months

    Time frame: Baseline and 12 months

  14. Change from Baseline in maximal phonatory time at 6 months

    Time frame: Baseline and 6 months

  15. Change from Baseline in dysphonia severity index (DSI) at 12 months

    Time frame: Baseline and 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.

  16. Change from Baseline in dysphonia severity index (DSI) at 6 months

    Time frame: Baseline and 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.

  17. Change from Baseline in cognition on the Montreal Cognitive Assessment at 12 months

    Time frame: Baseline and 12 months

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

  18. Change from Baseline in cognition on the Montreal Cognitive Assessment at 6 months

    Time frame: Baseline and 6 months

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

  19. Adverse events

    Time frame: up to 12 months after surgery

  20. Change from Baseline in balance ability on the Burg Balance Scale (BBS) at 6 months

    Time frame: Baseline and 6 months

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

  21. 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

    in the off-medication condition

Other outcomes

  1. Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months

    Time frame: Baseline and 12 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  2. Change from Baseline in stride length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months

    Time frame: Baseline and 6 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  3. Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months

    Time frame: Baseline and 12 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  4. Change from Baseline in stride velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months

    Time frame: Baseline and 6 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  5. Change from Baseline in step length on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months

    Time frame: Baseline and 12 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  6. Change from Baseline in step length on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months

    Time frame: Baseline and 6 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  7. Change from Baseline in step velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months

    Time frame: Baseline and 12 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  8. Change from Baseline in step velocity on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months

    Time frame: Baseline and 6 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  9. Change from Baseline in swing phase/stance phase on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months

    Time frame: Baseline and 12 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  10. Change from Baseline in swing phase/stance phase on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months

    Time frame: Baseline and 6 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  11. Change from Baseline in double support phase on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months

    Time frame: Baseline and 12 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  12. Change from Baseline in double support phase on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months

    Time frame: Baseline and 6 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  13. Change from Baseline in cadence on the Wearable Motion and Gait Quantification System (MATRIX) at 12 months

    Time frame: Baseline and 12 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

  14. Change from Baseline in cadence on the Wearable Motion and Gait Quantification System (MATRIX) at 6 months

    Time frame: Baseline and 6 months

    In the off-medication condition, the parameters will be recorded by the wearable quantification system during the walking test.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study 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

Acronym: ATS-PIGD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 31, 2022
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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