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Identifying Biomarkers and Changes in Cerebrospinal Fluid Collected Pre and Post Spinal Cord Stimulation in Subjects Suffering From Chronic Refractory Pain Conditions (CSF-STIM)

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ClinicalTrials.gov Identifier: NCT03986255
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

This is a single center exploratory study in subjects suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (CSF).

The study aims to identify any form of correlation between biological content of CSF and pain/treatment success. The study population include individuals suffering from chronic pain which has not been effectively treated with pharmacological treatment, medical intervention or alternative non-invasive treatments who have been scheduled for spinal cord stimulation.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Procedure: Lumbar Puncture Not Applicable

Detailed Description:

This is a single centre exploratory study in individuals suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (CSF).

The investigators aim to identify any form of correlation between biological content of CSF and pain/ spinal cord stimulator (SCS) therapy success. `

CSF will be sampled before and after SCS therapy, the samples will be analysed to explore and identify biomarkers that are potentially relevant to the chronic pain conditions

. All eligible participants who are enrolled in the study will undergo screening assessment. Specifically, assessments will include pain scores assessed by Visual Analogue Scale (VAS), quality of life as assessed by the EQ-5D, disability as assessed by the Oswestry Disability Index (ODI), quality of sleep as assessed by Pittsburgh Sleep Quality Index (PSQI), Pain sensation as assessed by Pain Map and neuropathic pain as assessed by Douleu Neuropathique 4 (DN4).

During trial implant participants will have CSF sample taken using lumbar puncture technique.

Following collection CSF sample will be analysed to Identify potential biomarkers.

All participants will return to the clinic 14 (± 7) days following the procedure to assess the outcome of their SCS trial and complete assessments which include Pain Map, Pain VAS, DN4 , PSQI , ODI , EQ-5D and Patients Global Impression of Change (PGIC).

Following this participants will be followed up for end of study visit. The second CSF sample will be taken at this visit using lumbar puncture technique. At this visit participants will further be asked to complete assessments including Pain Map, Pain VAS, DN4 , PSQI , ODI ,EQ-5D and PGIC.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Identifying Biomarkers and Changes in Cerebrospinal Fluid Collected Pre and Post Spinal Cord Stimulation: A Single Centre, Prospective, Exploratory Study in Subjects Suffering From Chronic Refractory Pain Conditions
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Lumbar Puncture
Participants will undergo Lumbar puncture procedure
Procedure: Lumbar Puncture

The participant is placed lateral or sitting position. Fluoroscopy may be used to guide sampling. Full aseptic technique is used throughout.

The skin is prepared with either 2% chlorhexidine/70% alcohol or iodine. 1% lidocaine is used for skin local anesthesia an entry point is identified, this may be done using fluoroscopy. This will be at the lowest intervertebral foramina interspace to minimize the risk of spinal cord injury. A small amount to head up tilt will be allowed to optimize CSF flow.

Sampling is done using a "needle through needle" technique. An epidural needle is used to identify the epidural space using loss of resistance to saline technique. A spinal needle (26G) is then passed through the epidural needle into the subarachnoid space. Correct entry is noted once CSF is noted in the needle hub and 5 ml taken. This sample is then sent off for analysis.

Once the CSF is sampled, the needle is removed and pressure applied to the skin entry point.





Primary Outcome Measures :
  1. Pain VAS [ Time Frame: 6 Months ]

    Visual Analogue Scale (VAS) used to assess improvements in pain. It is a continuous scale comprised of a horizontal line which is 10 centimeters (100mm) in length, anchored by 2 verbal descriptors, one which is no pain and the other worst imaginable pain. Lower scores denote a better outcome.

    Participants will be asked to complete this questionnaires at baseline and follow up visits.


  2. Pain Map [ Time Frame: 6 Months ]

    A pain checklist with a list of anatomical locations from which the participants selects relevant sites to the site of his/her pain. It is used to assess location of pain.

    Participants will be asked to complete this questionnaires at baseline and follow up visits.


  3. Oswestry Disability Index (ODI) [ Time Frame: 6 Months ]

    A self completed questionnaire used to assess changes in disability and health. The participants checks the statements which most closely resembles their situation. The scores for all the questions are summed with lower scores denote no disability.

    Participants will be asked to complete this questionnaires at baseline and follow up visits.


  4. Patient Global Impression of Change (PGIC) [ Time Frame: 6 Months ]

    Questionnaire used to assess patient satisfaction

    Participants will be asked to complete this questionnaires at follow up visits.

    .


  5. Douleur Neuropathique 4 (DN4) [ Time Frame: 6 Months ]

    A clinician-administered questionnaire consisting of 10 items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient and 3 items based on the clinical examination. The questionnaire used to assess neuropathic pain

    Participants will be asked to complete this questionnaires at baseline and follow up visits.


  6. EQ-5D-5L [ Time Frame: 6 Months ]

    A self report questionnaire used to assess improvements in quality of life.

    Participants will be asked to complete this questionnaires at baseline and follow up visits.


  7. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 6 Months ]

    A self report questionnaire that will used to assess improvements in sleep quality. The questionnaire consists of 19 items which measures several different aspects of sleep. Each item is weighted on a 0 - 3 interval scale, the overall score is calculated by totalling the seven component scores. Lower scores denote a healthier sleep quality

    Participants will be asked to complete this questionnaires at baseline and follow up visits.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be capable of understanding and signing a written consent form
  2. Subjects suffering from chronic neuropathic pain which has not been effectively managed with pharmacotherapy, medical interventions or alternative non-invasive treatments
  3. Pain VAS score ≥ 5 on more than 3 days a week at least over three months.
  4. Subjects deemed a suitable candidate receive spinal cord stimulator device as determined by a pain management specialist
  5. No known contraindication to spinal cord stimulation
  6. Does not have an active systemic or local infection

Exclusion Criteria:

  1. Structural abnormalities of the spine at L2-L3 that may impact study procedure
  2. Severe scoliosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986255


Contacts
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Contact: Samuel Wesley 0207 188 3237 gst-tr.PANARC@nhs.net

Locations
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United Kingdom
Guy's and St Thomas Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Elizabeth Bruna    02071889811    R&D@gstt.nhs.uk   
Principal Investigator: Adnan Al-Kaisy         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03986255     History of Changes
Other Study ID Numbers: CSF-STIM v1.0 22/OCT/2018
CSF-STIM ( Other Identifier: Guy's and St Thomas Hospital )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neuralgia
Pain, Intractable
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms