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Asleep Versus Awake ROSA robot assisted subthalamic nucleus Deep Brain Stimulation for Parkinson's disease: a prospective randomized controlled study

Asleep Versus Awake ROSA robot assisted subthalamic nucleus Deep Brain Stimulation for Parkinson's disease: a prospective randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032564
Enrollment
Unknown
Registered
2020-05-02
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

Asleep DBS:General anesthesia during the surgery
Awake DBS:Awake during the surgery

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with primary Parkinson's disease with a course of more than 4 years; 2. The mds-updrs III score of acute levodopa shock test improved more than 30% in patients sensitive to levodopa treatment; 3. Patients with symptom fluctuation or dyskinesia; 4. Patients aged 18-75 years; 5. Patients with normal head MRI; 6. Patients with normal cognitive function (MMSE >= 26); 7. In medicine, sleeping or awake operation is safe; 8. Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with Parkinson's superposition syndrome; 2. Patients with previous history of craniocerebral surgery (including mutilation and gamma knife surgery); 3. Patients with serious metabolic diseases; 4. Patients with serious heart, lung, kidney or liver diseases; 5. Patients with serious mental illness; 6. Patients with severe depression, clinically uncontrolled severe depression (BDI > 20) 7. Patients with severe cognitive decline; 8. Brain MRI showed obvious atrophy; 9. Pregnant or lactating women; 10. Patients with a history of attempted suicide; 11. Patients with obesity or serious potential respiratory problems; 12. The nuclei other than STN target were excluded.

Design outcomes

Primary

MeasureTime frame
Postoperative relief of disease in patients;

Secondary

MeasureTime frame
The change of levodopa equivalent dose, LED;the change of Neurocognitive Function;the change of Quality of life;Lead Placement;Stimulation Parameters;Operation Data;Stimulation related side effects;

Countries

China

Contacts

Public ContactXiaodong Cai

Shenzhen Second People's Hospital

13632660199@139.com+86 13632660199

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026