About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Stimulation ON
Device
Neurostimulation of the periaqueductal gray matter and sensory thalamus at a level with potential to provide pain relief
Stimulation Pseudo-ON
Device
Neurostimulation of the periaqueductal gray matter and sensory thalamus S at a low level, not designed to provide pain relief

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Stimulation ONActive comparator 1 intervention

Group B: Stimulation Pseudo-ONSham comparator 1 intervention

Trial outcomes

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

Time frame

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

Secondary outcomes

1

Numerical Rating Scale (NRS)

The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain. The anchors are 0 = no pain and 10 = extreme pain/worst possible pain (there are various different wording of the upper anchor). It is often categorised into: no pain = 0, mild pain = 1-3, moderate pain = 4-6, severe pain = 7-10

Time frame

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

2

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)

A short form of the McGill Pain Questionnaire (SF-MPQ), the main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The SF-MPQ also includes the Present Pain Intensity (PPI) index of the standard MPQ and a visual analogue scale (VAS).

Time frame

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

3

Brief Pain Inventory (BPI) - Short Form

The Brief Pain Inventory (BPI) is a 9 point self-report measure that assesses the intensity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief in the past 24 hours or the past week.

Time frame

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

4

Beck Depression Inventory (BDI II)

A 21-question self-report questionnaire used to measure the symptoms of depression in an individual

Time frame

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

Other outcomes

1

Heart rate variability (HRV)

HRV and other derivative autonomic variables measured for 7 days using VitalPatch.

Time frame

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

2

Client Service Receipt Inventory (CSRI)

Health economic data collection tool, used to data on healthcare service use

Time frame

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

3

MRI

Magnetic Resonance Imaging, recorded at 3 Tesla (T): Sequences = Structural, Diffusion Tensor Imaging (DTI) and resting state functional MRI (fMRI)

Time frame

Baseline (pre-operatively)

Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts