Automatic Control of Spinal Cord Stimulation

In patients with chronic pain implanted with spinal cord stimulator trial leads, do recordings of spinal cord potentials and automatic control of stimulation compared to standard manual control allow improvements to patient experience of treatment and pain relief

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001263987

Enrollment

Registered

2011-12-09

Start date

2011-11-21

Completion date

2013-08-21

Last updated

2025-10-06

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

Conditions

None listed

Brief summary

This study uses a newly developed spinal cord stimulator and measurement system. The aims of the study are: 1. To determine if the nerve response to stimulation recorded from the spinal cord can be used to maintain the stimulation at a constant and comfortable level for the patient. 2. To make measurements from the spinal cord to optimise the stimulator settings automatically. 3. To determine different stimulation patterns to provide pain relief without the patient feeling the stimulation. 4. To determine if a patient’s pain can be detected from the nerve signals measured in the spinal cord.

Interventions

Patients who have already been implanted with a commercial trial spinal cord stimulation leads will have their implanted leads temporarily connected to a new spinal cord stimulation and recording system. The new system will record nerve responses from the spinal cord stimulation and use those responses to automatically control the stimulation. Patients will be tested in 1 or 2 sessions of up to 4 hours each during their usual trial stimulation period of 4-7 days. Different stimulation paradigms will be tested within subject, crossing-over between automatic control and standard manual control, with a duration in each arm of several minutes up to an hour, with no washout period. Each stimulation paradigm will be tested during various posture changes. The aims of the study are: 1. To determine if the nerve response to stimulation recorded from the spinal cord can be used to maintain the stimulation at a constant and comfortable level for the patient. 2. Measuring from the spinal cord to optimise the stimulator settings automatically. 3. Determine different stimulation patterns to provide pain relief without the patient feeling the stimulation. 4. To determine if a patient’s pain can be detected from the nerve signals measured in the spinal cord.

Study design

Allocation

Non-randomised trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients implanted with a commercially available electrode lead who are part of a routine clinical trial stimulation program prior to possible permanent implant. Patients are capable of fulfilling the requirements of this protocol including reporting of patient percepts.

Exclusion criteria

Patients implanted with a commercially available electrode lead who have had complications such that the implanted electrodes are not able to stimulate and record over the spinal cord.

Outcome results