Differential Target Multiplexed Spinal Cord Stimulation for the Treatment of Chronic Intractable Upper Limb Pain: 12-Month Results From a Prospective, Multicenter Study.

OBJECTIVES: This prospective, open-label, single-arm, multicenter study evaluated the use of differential target multiplexed (DTM) spinal cord stimulation (SCS) therapy for chronic upper limb pain (ULP). MATERIALS AND METHODS: A total of 58 candidates for SCS who had chronic ULP were enrolled at 11 sites in the USA. The safety and effectiveness of DTM SCS for treating chronic intractable ULP were evaluated over 12 months. The primary end point was the percentage of responders (≥50% ULP relief versus baseline) to treatment at three months after device activation. This study also evaluated the extent of disability, patient satisfaction, and patient global impression of change with DTM SCS therapy. RESULTS: The mean baseline pain score (10-cm visual analog scale [VAS-10]) for ULP was 7.2 cm, with a mean age of 56 years and mean ULP duration of ten years; 47 subjects were assessed at the primary end point. The percentage of ULP responders was 92% at three months, which was consistent at six (91%) and 12 months (86%). Significant ULP relief (81% reduction in VAS-10) was observed at the primary end point and sustained throughout the study duration. Significant improvements in disability in addition to high levels (>95%) of satisfaction and feelings of improvement were reported. Frequency of study-related anticipated adverse events was in line with expectations of SCS therapy. CONCLUSION: In this patient population with difficult-to-treat conditions with limited clinical evidence of the effectiveness of SCS, subjects reported significant reduction in chronic ULP in response to treatment with DTM SCS.

Using Lower Amplitudes to Maintain Effective High Dose Spinal Cord Stimulation Therapy (SCS Dosing Pilot Study).

BACKGROUND: Spinal cord stimulation is an effective therapy for chronic back and/or leg pain. Amplitude dose-response studies are lacking; therefore, little guidance exists regarding the minimum amplitude requirements with specific high dose parameters. This study characterized the minimum amplitude level that maintained SCS therapy satisfaction and pain relief when stimulating at 1000 Hz and 90 µsec. MATERIALS AND METHODS: Qualified patients had back and leg pain, an implanted neurostimulator programmed to 1000 Hz and 90 µsec, and were very or somewhat satisfied with the therapy, and an average overall VAS pain score ≤ 4 from a daily diary. Patients received four blinded amplitudes (titrated from 80%, 60%, 40%, and 20% of baseline perception threshold), approximately two weeks each, with 1000 Hz and 90 µsec and position-adaptive stimulation enabled. Patients' satisfaction and overall VAS pain scores were collected for each period. All patients continued through the study, even after reporting lack of therapy satisfaction or pain relief. RESULTS: The minimum amplitude, which maintained therapy satisfaction, was 80% of perception threshold for two patients, 60% for one patient, and 20% for 21 patients. Additionally, six patients lost satisfaction changing from their baseline amplitude to 80% perception threshold. The minimum amplitude level, which maintained overall pain relief, was 80% perception threshold for three patients, 60% perception threshold for one patient, 40% perception threshold for two patients, and 20% perception threshold for 19 patients. Five patients required the setting they were programmed to during the baseline period. CONCLUSION: The qualified study patients defined an implanted population reporting good pain relief and satisfaction using HD SCS therapy at baseline. The majority of these patients were able to maintain therapy satisfaction and pain relief (70% and 63.3%, respectively) with 20% perception threshold amplitude. Amplitudes below perception threshold could potentially maintain effective SCS therapy with HD stimulation in a subset of patients.

Nucleus caudalis dorsal root entry zone lesioning for the treatment of anesthesia dolorosa.

Deafferentation facial pain (anesthesia dolorosa) can occur after injury of the first-order trigeminal nerve. It is often debilitating and difficult to treat. The authors report the treatment of anesthesia dolorosa in a 69-year-old man with a 7-year history of pain. The pain occurred after an open resection of a right trigeminal neuroma. After treatment with medications failed, the patient was treated with nucleus caudalis (dorsal root entry zone) lesioning. His facial pain was immediately and completely eliminated. The authors describe the technique of this central neuroablative procedure, and they review the available literature regarding this procedure as well as the current evidence base for neuromodulatory surgeries. After the 1-year follow-up, the authors conclude that the patient attained lasting relief.

Nucleus caudalis lesioning: Case report of chronic traumatic headache relief.

BACKGROUND: The nucleus caudalis dorsal root entry zone (DREZ) surgery is used to treat intractable central craniofacial pain. This is the first journal publication of DREZ lesioning used for the long-term relief of an intractable chronic traumatic headache. CASE DESCRIPTION: A 40-year-old female experienced new-onset bi-temporal headaches following a traumatic head injury. Despite medical treatment, her pain was severe on over 20 days per month, 3 years after the injury. The patient underwent trigeminal nucleus caudalis DREZ lesioning. Bilateral single-row lesions were made at 1-mm interval between the level of the obex and the C2 dorsal nerve roots, using angled radiofrequency electrodes, brought to 80°C for 15 seconds each, along a path 1 to 1.2 mm posterior to the accessory nerve rootlets. The headache improved, but gradually returned. Five years later, her headaches were severe on over 24 days per month. The DREZ surgery was then repeated. Her headaches improved and the relief has continued for 5 additional years. She has remained functional, with no limitation in instrumental activities of daily living. CONCLUSIONS: The nucleus caudalis DREZ surgery brought long-term relief to a patient suffering from chronic traumatic headache.

Trigeminal nucleus caudalis anatomy: guidance for radiofrequency dorsal root entry zone lesioning.

OBJECT: This study seeks to improve the accuracy of trigeminal nucleus caudalis dorsal root entry zone (DREZ) radiofrequency lesioning by quantifying the size and orientation of the nucleus caudalis. METHODS: Using serial axial photographs of 6 formalin-fixed cadaver brainstems, digital nucleus caudalis measurements were taken at 1-mm intervals from the level of the obex to the C(2) dorsal nerve roots. RESULTS: From the obex to the C(2) dorsal nerve roots, the nucleus caudalis decreases in width (from 2.6 ± 0.2 to 1.0 ± 0.3 mm) and, excluding superficial tract thickness, decreases in axial nucleus depth (from 2.4 ± 0.3 to 1.7 ± 0.2 mm). At levels between the obex and 10 mm caudal to the obex, the accessory nerve rootlets exit the brainstem at the junction of the spinal trigeminal tract and the dorsal spinocerebellar tract. CONCLUSION: This study details the anatomic dimensions and orientation of the nucleus caudalis for surgeons who perform DREZ lesioning.