Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation

NCT06387914 | Recruiting DMC

• 2 other identifiers: PID 1670723/WM/0219
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat severe pain following a stroke in adults. It will also learn about the safety of deep brain stimulation. The main questions it aims to answer are:

• Does DBS lower the pain score in these participants.
• What medical problems do participants have when having DBS? Researchers will compare different settings, to see if DBS works to treat severe post stroke pain. Participants will:
• Undergo baseline screening procedures and have an MRI scan.
• Have neurosurgery to put the DBS system in
• Have follow up for 10 months
• Visit the clinic at least 5 times in the study for check-ups and tests
• Fill in questionnaires about pain and mood and have check ups remotely

Conditions

Central Post Stroke Pain

Keywords

Deep Brain Stimulation; Neuropathic pain; Central Post Stroke Pain; Randomised Controlled Trial; Sensory thalamus; Periaqueductal Gray

Outcome Measures

Primary Outcomes (1)

• McGill Pain Questionnaire V2.0 -Short Form - Present Pain Intensity (MQ-SF-PPI) score

  The SF-MPQ also includes the Present Pain Intensity (PPI) index of the standard MPQ

  MQ-SF-PPI at end of Month 3 and Month 4: Comparison is between intervention (DBS ON vs DBS Pseudo-ON)

Secondary Outcomes (8)

• Numerical Rating Scale (NRS)

  Baseline (pre-operatively), Pre-switch on, Randomisation month (weekly),'Crossover' (weekly), monthly during Optimisation to study end. Ad Hoc programming change, MPQ-SF PPI subscale recorded pre- and 30 mins post

• McGill Pain Questionnaire V2.0 short form (MPQ-SF) McGill Pain Questionnaire V2.0 short form) MPQ-SF (McGill Pain Questionnaire V2.0 short form)

  Baseline (pre-operatively), Pre-switch on, Randomisation month (weekly),'Crossover' (weekly), monthly during Optimisation to study end. Ad Hoc programming change, MPQ-SF PPI subscale recorded pre- and 30 mins post

• Brief Pain Inventory (BPI) - Short Form

  Baseline (pre-operatively), post-operatively at months 2, 3, 7 and 10 (study end)

• Beck Depression Inventory (BDI II)

  Baseline (pre-operatively), post-operatively at months 2, 3, 7 and 10 (study end)

• Patients' Global Impression of Change (PGIC)

  Post-operatively at months 2, 3, 7 and 10 (study end)

Other Outcomes (3)

• Heart rate variability (HRV)

  Five 7 day periods: Pre-operatively and post-operatively at months 1, 2, 3, 7.

• Client Service Receipt Inventory (CSRI)

  Baseline (pre-operatively), post-operatively at months 2, and 7

• MRI

  Baseline (pre-operatively)

Study Arms (2)

Stimulation ON

ACTIVE COMPARATOR

ON stimulation is a programme that on average provides pain relief to participants based on previous experience with DBS for pain. There will be some titration of stimulation, based on patient response. The setting with best acute pain relief will be the one chosen for the ON phase, with individual parameter settings up to a maximum of: Frequency up to 80 Hertz(Hz), Amplitude 6.0 milliamps(mA) and or Pulse Width 500 microseconds(uS). Duration of intervention: 1 month

Device: Stimulation ON

Stimulation Pseudo-ON

SHAM COMPARATOR

Pseudo-ON is a low power programme that provides sham stimulation (high frequency, low amplitude stimulation generally ineffective at providing pain relief) and drains battery over time, requiring the participant to recharge the IPG periodically: around 250Hz, less than 0.5mA (with potential to be as low as 0mA), 450uS. Duration of intervention: 1 month

Device: Stimulation Pseudo-ON

Interventions

Stimulation ON DEVICE

Neurostimulation of the periaqueductal gray matter and sensory thalamus at a level with potential to provide pain relief

Also known as: Picostim-DyNeuMo-2

Stimulation ON

Stimulation Pseudo-ON DEVICE

Neurostimulation of the periaqueductal gray matter and sensory thalamus S at a low level, not designed to provide pain relief

Also known as: Picostim-DyNeuMo-2

Stimulation Pseudo-ON

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give informed consent for participation in the trial.
• Willing and able to follow pre and post-operative procedures in Oxford.
• Aged 21 years or above.
• Diagnosed as having central post stroke pain of 2 years' minimum duration refractory to best medical/non-medical treatment
• Mean usual VAS (or NRS) pain score \> 6/10 despite input from a multidisciplinary pain team.

You may not qualify if:

• A patient will not be eligible for the trial if any of the following apply:
• Contraindication for elective general anaesthesia, for example but not limited to severe cardiovascular disease, hyponatraemia, hyperkalaemia, etc.
• Previous implantation of a DBS device with device still in situ.
• Contraindication to MRI
• Contraindication to neurosurgery, e.g. Bleeding disorders, not able to stop anticoagulation safely for perioperative phase (approx. 10 days, 5 days pre-operatively, 5 days postoperatively) Major psychiatric or cognitive disorder that may affect mental capacity that is untreated or may otherwise affect the participant's ability to engage in the trial
• Active skin-based infection or colonisation with a multi-drug resistant organism e.g. methicillin-resistant Staphylococcus aureus (MRSA)
• Requires regular MRI investigations post-operatively
• Likely to require diathermy, ultrasound or transcranial magnetic stimulation post DBS device insertion
• Not tolerant of awake surgery
• Unable to cooperate with device recharging
• Pregnancy or planned pregnancy
• In the investigator's opinion unable to comply with the protocol

Sponsors & Collaborators

• University of Oxford: lead
• Jon MoultonTrust: collaborator
• Placito Bequest: collaborator
• Bioinduction: collaborator

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Green, MD, DPhil

  Nuffield Department of Surgical Sciences

  PRINCIPAL INVESTIGATOR

• Timothy Denison, PhD

  Institute of Biomedical Engineering, Old Road Campus Research Building, Oxford OX3 7DQ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Green, MD, DPhil

CONTACT

+441865234762; alex.green@nds.ox.ac.uk

Martin Gillies, PhD

CONTACT

+441865227577; epione_dbs_pain@nds.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding maintained using the hand held controller (shows ON at all times) and programs which ensure equivalent battery drain at all stimulation settings. Pseudo-ON = a low power programme that provides 'sham stimulation' (high frequency, low amplitude stimulation generally ineffective at providing pain relief) and drains battery over time, requiring the participant to recharge the IPG periodically: around 250Hz, less than 0.5mA (with potential to be as low as 0mA), 450uS.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind trial, within subject randomisation and cross-over.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 29, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: When summary data are published or otherwise made available, requests will be considered, as per the plan (detailed in the CIP)

Locations

GB (1)