Chronic Neuropathic PainNCT07820657
EEG Theta Band Rhythm in SCS
A study testing Reversal in EEG Theta Power in people with Chronic Neuropathic Pain, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Neuropathic Pain
- What is being tested?
- Reversal in EEG Theta Power
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jun 2022to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with history of epilepsy or epileptiform disorders
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Walton Centre NHS Foundation Trust
Liverpool, Merseyside, L97LJ
About this study
Official title: Reversal of EEG Theta Rhythm as an Objective Measure of Efficacy of Spinal Cord Stimulation in Chronic Neuropathic Pain - a Pilot Study
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.
Read the detailed description
The aim of the study is to see if reversal in EEG theta power during trial period can predict a sustained response (At 6 months post implantation) and thus serve as an objective measure for SCS efficacy in a given patient, thus objectively identifying true responders.
Additionally, this study aims to see if spinal profile of baseline EEG abnormality as well as EEG response to a given SCS modality during trial period, alongside clinical correlation, can help in selection of SCS modality best suited to a given patient.
- Conditions
- Chronic Neuropathic Pain
- Being tested
- Reversal in EEG Theta Power
- Keywords
- EEG Theta Band Rhythm, Spinal Cord Stimulation, EEG, Chronic Neuropathic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Reversal in EEG Theta power during trial period | Experimental | Not described Receives: Device: Reversal in EEG Theta Power |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction in theta (4-7 Hz) power
Used to differentiate responders from non-responders
Measured: Up to day 11 following trial lead implementation
Secondary outcomes (2)
Spatial profile of EEG changes
Used to predict patient suitability to an SCS modality
Measured: Up to day 11 following trial lead implementation
reduction in short and mid latency amplitude on SSEP
Used to predict patient suitability to an SCS modality
Measured: Up to day 11 following trial lead implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start16 Jun 2022
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walton Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepti Bhargava, Principal investigator, Walton Centre NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820657
- Sponsor's protocol ID
- RG349-20
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of EEG Theta Rhythm as an Objective Measure of Efficacy of Spinal Cord Stimulation in Chronic Neuropathic Pain - a Pilot Study
- ClinicalTrials.gov ID
- NCT07820657
- Acronym / sponsor ID
- RG349-20
- Conditions
- Chronic Neuropathic Pain
- Keywords
- EEG Theta Band Rhythm, Spinal Cord Stimulation, EEG, Chronic Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Walton Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of the study is to see if reversal in EEG theta power during trial period can predict a sustained response (At 6 months post implantation) and thus serve as an objective measure for SCS efficacy in a given patient, thus objectively identifying true responders.
Additionally, this study aims to see if spinal profile of baseline EEG abnormality as well as EEG response to a given SCS modality during trial period, alongside clinical correlation, can help in selection of SCS modality best suited to a given patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reversal in EEG Theta power during trial period | Experimental | Device: Reversal in EEG Theta Power |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with history of epilepsy or epileptiform disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reversal in EEG Theta Power32 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. | Device | Reversal in EEG Theta power during trial period |
Primary outcome
The reduction in theta (4-7 Hz) power
Time frame: Up to day 11 following trial lead implementation
Used to differentiate responders from non-responders
2 secondary outcomes
Spatial profile of EEG changes
Time frame: Up to day 11 following trial lead implementation
reduction in short and mid latency amplitude on SSEP
Time frame: Up to day 11 following trial lead implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepti Bhargava principal investigator
Walton Centre NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reversal in EEG Theta Power in people with Chronic Neuropathic Pain, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction in theta (4-7 Hz) power (time frame: Up to day 11 following trial lead implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.