Spinal Cord Stimulation in Small Fibre Neuropathy

NCT02905396 | Terminated DMC

• 2 other identifiers: SFN-SCSNL53831.06.15/ METC152054
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as burning pain in the extremities in combination with autonomic symptoms. So far, the results of symptomatic SFN treatment have been rather disappointing, despite the fact that new agents have been developed. This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in patients suffering from pain in the lower limbs due to SFN, defined as ≥30% pain reduction on a mean NRS during daytime, and/or ≥30% pain reduction on a mean NRS during night-time, and/or at least much improved or very much improved, on the Patient Global Impression of Change (PGIC) for pain and sleep.

Conditions

Small Fiber Neuropathy

Keywords

small fiber neuropathy; spinal cord stimulation; treatment; pain

Outcome Measures

Primary Outcomes (1)

• Pain relief

  The primary objective of this study is to investigate whether SCS combined with best (drug) treatment as usual (TAU) leads to clinically significant (≥30%) pain relief in patients suffering from pain in the lower limbs due to SFN after 12 months of treatment. Clinical significant pain relief is determined as: 1. ≥30% pain reduction on the mean daytime pain using the NRS, and/or 2. ≥30% pain reduction on the night-time pain using the NRS and/or 3. At least much improved or very much improved on the Patient Global Impression of Change (PGIC) for pain and sleep.

  Up to 1 year

Secondary Outcomes (6)

• Pain reduction

  Up to 1 year

• Activity and participation

  Up to 1 year

• Quality of life

  Up to 1 year

• Mood

  Up to 1 year

• Reduction of pain medication

  Up to 1 year

Study Arms (1)

Spinal cord stimulation

EXPERIMENTAL

implantation of spinal cord stimulator

Device: Spinal cord stimulation

Interventions

Spinal cord stimulation DEVICE

implantation of spinal cord stimulator

Also known as: Neurostimulation, PrimeAdvanced SureScan MRI-neurostimulator Model 97702 Medtronic

Spinal cord stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SFN diagnosis according to international criteria,
• Age between 18 and 75 years, lucid,
• Mean pain intensity during daytime or night-time should be 5 or higher on the 11-points numeric rating scale (NRS),
• The pain intended to treat has been present for more than 12 months, as declared by patients to the best of their knowledge or after studying available medical records,
• Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects) with drugs from the following drug categories
• Tricyclic anti-depressant agent (e.g., Amitriptyline)
• Alpha 2-delta calcium channel agonist/Anti-epileptic drugs (e.g. Pregabalin (Lyrica) or Gabapentin (Neurontin)),
• Serotonin-norepinephrine reuptake inhibitors (e.g., Duloxetine (Cymbalta)),
• Tramadol or strong opioids.
• Patients will have to be treated or have been treated with at least 3 drugs from the above mentioned drug categories according to the EFNS guidelines for neuropathic pain \[34\]. Starting dosage is based on individual patient characteristics. Each drug has to be tried for at least 3 weeks and dose will have to be raised once, if possible. Drug treatment can be stopped due to insufficient pain relief and/or unacceptable adverse events.

You may not qualify if:

• Neuromodulation in history,
• Neuropathic pain prevalent in the upper limbs (UL) compared to the legs; UL NRS not exceeding 3)
• Neuropathy or chronic pain of other origin than SFN (NRS \> 3),
• Addiction: drugs, alcohol (5E / day) and/or specific medication
• Drugs: cocaine, heroin, marihuana,
• Alcohol: wine, beer, liquor,
• Medication: benzodiazepines.
• Insufficient cooperation from the patient (little motivation, understanding or communication problems),
• Blood clotting disorder or the use of oral anticoagulation that cannot be stopped for a period of 10 days around the implantation procedure.
• Immune deficiency (HIV-positive if known, corticosteroids with a dose equivalent to \> prednisolone 10 mg, immunosuppressive medication, etc.)
• Life expectancy \< 1 year
• Pacemaker
• Local infection or other skin disorders at site of incision
• Other clinically significant or unstable, or severe acute or chronic medical or psychiatric/psychological condition or laboratory abnormality that may increase the risk associated with study participation or procedure or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Pregnancy

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Small Fiber Neuropathy; Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 19, 2016
• Study Start: July 1, 2018
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

NL (1)