Actively Recruiting
A Study of the Safety and Tolerability of GA in the Treatment of Patients With Refractory Neuropathic Pain
Led by Beijing Tiantan Hospital · Updated on 2026-01-22
6
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Previous studies have shown that the anterior cingulate cortex is involved in the regulation of pain and its associated negative emotions, that pyramidal neurons are highly excitable in chronic neuropathic pain conditions, and that silencing of pyramidal neurons can eliminate pain. The aim of this study was to evaluate the safety, tolerability, and efficacy of intracranial injection of GA (containing the hM4Di gene) in the anterior cingulate cortex in combination with oral clozapine for the treatment of refractory neuropathic pain.
CONDITIONS
Official Title
A Study of the Safety and Tolerability of GA in the Treatment of Patients With Refractory Neuropathic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years with a confirmed diagnosis of neuropathic pain, including painful diabetic peripheral neuropathy, trigeminal neuralgia, or post-stroke pain
- Regular treatment with conventional therapies for at least 3 months without symptom relief or tolerance
- Completed a full course of treatment with at least two first-line medications
- Pain intensity with a mean visual analogue scale (VAS) score of 4 cm or higher and/or numerical rating scale (NRS) score of 4 points or higher within one week before enrollment
- Stable analgesic regimen for at least 30 days prior to enrollment and agreement not to change medication type or dose during the trial
- Voluntary participation with signed informed consent
- Stable neurological status based on motor, sensory, and reflex assessments
- Ability to comply with study protocols, including understanding and completing scales and visits
- For those of childbearing potential, agreement to use effective contraception (excluding oral contraceptives) and no plans to have children or donate sperm or eggs during the study
You will not qualify if you...
- Amputation or large (3 cm or more) and/or gangrenous ulcers on the lower limbs in patients with diabetic peripheral neuropathy
- Progressive neurological disorders such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, brain or spinal cord tumors, or neurodegenerative diseases
- Severe cardiopulmonary diseases including unstable angina, myocardial infarction, severe arrhythmia, or recurrent asthma
- Malignant tumors of the central nervous system or other systems
- Conditions affecting surgery including coagulation disorders, platelet dysfunction, severe cardiac or pulmonary disease, or progressive peripheral vascular disease
- Current use of anticoagulants that cannot be stopped
- Local or systemic infection at the expected surgical site
- History of intracranial surgery except minimally invasive diagnostic procedures
- Severe psychiatric conditions or significant suicidal tendencies
- Severe liver, kidney, or heart dysfunction as defined by specific lab or clinical criteria
- History of delirium, hypotension, epilepsy, glaucoma, myelosuppression, CNS depression, or coma
- Abnormal laboratory test values including low white blood cell or platelet counts, abnormal coagulation, or high blood adeno-associated virus antibody titers
- Use of drugs causing granulocyte deficiency or prior clozapine-induced severe granulocytopenia
- Allergies or contraindications to trial medications or components
- Gastrointestinal diseases or surgeries affecting drug absorption or metabolism
- Previous gene or cellular therapy
- History of alcohol or drug abuse
- Participation in other clinical trials or investigational treatments within 6 months
- Contraindications to MRI or functional MRI such as claustrophobia or metallic implants
- Serious clozapine-related adverse reactions during screening as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
Y
Yahui Zhu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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