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Efficacy and safety of implantable deep brain stimulation system in the treatment of chronic neuropathic pain

Efficacy and safety of implantable deep brain stimulation system in the treatment of chronic neuropathic pain

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032654
Enrollment
Unknown
Registered
2020-05-05
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

Chronic neuropathic pain

Interventions

Operation group:Deep brain stimulation

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18-70 years old, gender unlimited. 2. At least 6 months after the diagnosis of neuropathic pain, which seriously affects the work and daily life of patients. 3. The NRS of the past 30 days is more than 5. 4. Failure in treatment by various drugs, physical therapy, nerve block, transcranial magnetic stimulation (TMS). 5. Patients and their families can fully understand the treatment and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious intracranial diseases, such as intracranial hemorrhage, hemorrhagic infarction and large area infarction. 2. Serious other basic diseases, including uncontrolled hypertension, serious diabetes, major organ system failure, anticoagulation therapy, active infection, low immune function or malignant tumor with life expectancy less than 5 years. 3. In addition to nervous system diseases causing chronic pain, there are other nervous system diseases, including epilepsy, neurodegenerative diseases or any history of epileptic seizures. 4. Severe cognitive impairment or dementia (MoCA 20) or other untreated or uncontrolled mental diseases (active anxiety, schizophrenia, bipolar disorder, obsessive-compulsive disorder or personality disorder (such as multiple personality disorder, borderline personality disorder, etc.) or other neuropsychiatric diseases recommended by psychiatrists after evaluation. 8. Patients with implanted electronic devices, such as nerve stimulators, pacemakers or drug pumps. 9. Attempted suicide within the last 6 months. 10. There has been a history of drug abuse in the past three years. 11. Pregnant or lactating women, and who intend to be pregnant during the clinical study. 12. Patients who significantly increase the risk or significantly reduce the likelihood of DBS benefits in the judgment of the investigator may be excluded.

Design outcomes

Primary

MeasureTime frame
NRS;McGill pain questionnaire, MPQ;

Secondary

MeasureTime frame
Hamilton Depression Scale, HAM;36-Item Short Form Health Survey,SF-36;Operation related complications;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