Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads (RestoreSensor)

Justin Parker Neurological Institute

Status: Completed

Conditions: Chronic Refractory Low Back and Leg Pain

Treatments: Device: RestoreSensor Neurostimulation

Study type: Observational

Funder types: Other

Identifiers

NCT01874899

JPNI-3

Details and patient eligibility

About

The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.

Full description

A single-center, prospective, randomized study with a two-arm crossover design. The primary objective of this study is to establish threshold and therapeutic stimulation parameters for the RestoreSensor neurostimulator in response to postural changes. The secondary objective is to compare the effectiveness of spinal cord stimulation with manual versus automatic position-adaptive settings for chronic refractory low back and/or extremity pain.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Skeletally mature adults between 18 and 70 years old
• Patients with chronic refractory back and/or leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions
• > 50% pain reduction during the trail period
• Willing and able to comply with the requirements of the protocol including follow-up requirements
• Willing to sign a study specific informed consent

Exclusion criteria

• Previous SCS treatment
• Surgically remediable spinal condition
• Active local or systemic infection

Trial design

18 participants in 2 patient groups

Manual, then Automatic Stimulation

Description:

The RestoreSensor neurostimulator will be programed for manual stimulation adjustments and the patients will crossover to automatic stimulation group after 1.5 months

Treatment:

Device: RestoreSensor Neurostimulation

Automatic, then Manual Stimulation

Description:

The RestoreSensor neurostimulator will be programed for automatic stimulation adjustments and the patients will crossover to manual stimulation group after 1.5 months.

Treatment:

Device: RestoreSensor Neurostimulation