Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

⁃ A patient will be eligible for inclusion in this trial if all of the following criteria apply:

• 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.

Locations
Other Locations
United Kingdom
John Radcliffe Hospital
RECRUITING
Oxford
Contact Information
Primary
Alexander Green, MD, DPhil
alex.green@nds.ox.ac.uk
+441865234762
Backup
Martin Gillies, PhD
epione_dbs_pain@nds.ox.ac.uk
+441865227577
Time Frame
Start Date: 2024-08-07
Estimated Completion Date: 2028-12
Participants
Target number of participants: 30
Treatments
Active_comparator: Stimulation ON
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
Sham_comparator: Stimulation Pseudo-ON
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
Related Therapeutic Areas
Sponsors
Leads: University of Oxford
Collaborators: Jon MoultonTrust, Placito Bequest, Bioinduction

This content was sourced from clinicaltrials.gov