Study of new stimulation for neuropathic pain following a spinal cord lesion

JRCT ID: jRCT1042220093

Registered date:21/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neuropathic pain following a spinal cord lesion
• Date of first enrollment: 21/11/2022
• Target sample size: 10
• Study type: Interventional

Intervention(s)

In order to evaluate the research hypotheses that spinal cord stimulation (SCS) using new stimulation method of differential target multiplexed (DTM) stimulation via a paddle lead placing at the rostral side of the spinal lesion is more effective than conventional stimulation via cylinder-type electrodes locating at the rostral side.
First step, cylinder-type electrodes is inserted on the caudal side of the spinal cord lesion under local anesthesia.
Then, SCS trial is performed for 6 days and assessments of efficacy of conventional and DTM stimulations. In cases of effective of SCS trial or a patient demands implantation of SCS system even if non-effective of SCS trial, proceed to the second steps.
Second step, a paddle-type electrode is placed at the rostral side of the spinal cord lesion by laminectomy under general anesthesia. At the same time, an implantable pulse generator is implanted. Then, DTM stimulation keeps going, and the effect is assessed at 3 months after the implantation surgery.

Outcome(s)

• Primary Outcome: Evaluate of effective rates of the new methods at the time of 3 months after the implantation surgery compared with preoperative. Effective is defined as achieving more than 33% for pain improvement by VAS.

Secondary Outcome

1) Assessments of effect of SCS trial.
2) Evaluation of changes in pain scale: VAS, SF-MPQ-2 (Short-Form McGill Pain Questionnaire-2), mental score: PCS (Pain Catastrophizing Scale), Simple Depressive Symptom Scale, and comprehensive health: SF-36 (MOS Short-Form 36-Item Health Survey) at 1, 3, 6, 12, 18 months, and at the time of final follow-up (24 months) from spinal cord stimulation system implantation.
3) Examination of the relationship between the presence or absence of SCS trial and the effect of pain relief after spinal cord stimulation system implantation.
4) Defines long-term effects as that continue for more than 12 months, and detects factors associated with long-term effects.
5) Evaluation whether there is improvement of motor function using the gait function scale: FAC (Functional Ambulation Categories) at 1, 3, 6, 12, 18 months, and at final follow-up (24 months) from spinal cord stimulator implantation.
6) Extraction of diseases related to this study at 3 months after the implantation surgery.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Patients with intractable neuropathic pain following spinal cord lesion resistance to medication treatments
-18 years of age or older
-Pain scale of VAS (Visual analog scale) is more than 4 point
-Patients who classified as Frankel grade: B-E
-Patients in whom a paddle-shaped lead can be placed on the rostral side of the spinal cord lesion
-Patients who have obtained written consent from the patient

Exclude criteria

-Patients for whom local and general anesthesia cannot be performed
-Patients who classified as Frankel grade A
-Patients receiving anti-cancer therapy
-Patients with a history of drug abuse
-Patients with high risk of surgery, such as patients with unstable angina pectoris and with end-stage liver disease presenting with hepatic encephalopathy
-Patients with diabetes mellitus who are not well controlled (HbA1c 9% or more)
-Patients with serious complications (liver disease, kidney disease, heart disease, lung disease, blood disease, brain disease, etc.)
-Pregnant or potentially pregnant patients
-Patients who are considered as inappropriate by a head of research or research assignations

Related Information

• Primary Sponsor: Saito Ryuta