NCT07820657

Brief Summary

The investigators want to assess if reversal in EEG theta power during trial phase can serve as an objective marker for sustained clinical response, identifying true responders, and if the changes in EEG pattern during trial with three modalities can help in selection of SCS modality best suited to a given patient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

2.1 years

First QC Date

September 3, 2026

Last Update Submit

September 23, 2026

Conditions

Chronic Neuropathic Pain

Keywords

EEG Theta Band RhythmSpinal Cord StimulationEEGChronic Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • The reduction in theta (4-7 Hz) power

    Used to differentiate responders from non-responders

    Up to day 11 following trial lead implementation

Secondary Outcomes (2)

  • Spatial profile of EEG changes

    Up to day 11 following trial lead implementation

  • reduction in short and mid latency amplitude on SSEP

    Up to day 11 following trial lead implementation

Study Arms (1)

Reversal in EEG Theta power during trial period

EXPERIMENTAL
Device: Reversal in EEG Theta Power

Interventions

Reversal in EEG Theta PowerDEVICE

32 lead EEG at baseline on day of surgery prior to trial lead implementation. Stimulation shall be started with high frequency and burst modes in alternate patients. First follow up EEG shall be performed with stimulation on day 3. Stimulation will then be switched over to the low frequency mode and a further EEG on this mode will be obtained on day 7. After this the third mode shall be tried and further EEG obtained on day 11. At this point, trial shall be concluded as per normal practice.

Reversal in EEG Theta power during trial period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (Aged 18 years or above and able to consent) with failed back surgery syndrome leading to neuropathic leg/back pain deemed suitable for spinal cord stimulation trial

You may not qualify if:

  • Patients with history of epilepsy or epileptiform disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Walton Centre NHS Foundation Trust

Liverpool, Merseyside, L97LJ, United Kingdom

Location

Study Officials

  • Deepti Bhargava

    Walton Centre NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 15, 2026

Study Start

June 16, 2022

Primary Completion

August 6, 2024

Study Completion

August 6, 2024

Last Updated

September 28, 2026

Record last verified: 2026-09

Locations

GB(1)