Clinical Trials Logo
  1. Home
  2. Peripheral Nerve Injuries
  3. NCT03082820
  4. Details
NCT03082820 Clinical Trial

Pain-related Evoked Potentials in Unilateral Peripheral Nerve Injuries

Peripheral Nerve Injuries Clinical Trial

Official title:
Evaluation of Pain-related Evoked Potentials (PREP) for the Objectivization of Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03082820
Other study ID # PREP2015
Secondary ID
Status Completed
Phase N/A
First received March 6, 2017
Last updated March 17, 2017
Start date February 3, 2015
Est. completion date November 5, 2016

Study information
Verified date March 2017
Source Ruhr University of Bochum
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study examines pain-related evoked potentials (PREP) in patients with peripheral nerve injuries. Since previous studies found altered latencies and amplitudes of PREP in generalized polyneuropathies, e. g. HIV-polyneuropathy and fibromyalgia, this study investigates if these alterations are detectable in unilateral peripheral nerve injuries as well.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date November 5, 2016
Est. primary completion date November 5, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Peripheral Nerve Injury

Exclusion Criteria:

- Polyneuropathy

- Contralateral peripheral nerve injury

- Severe psychiatric disorders

- Disorders affecting central nervous system

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Pain-related evoked potentials (PREP)
PREP were performed bilaterally with a concentric surface electrode at twice the individual pain threshold.
• Quantitative Sensory Testing (QST)
QST was performed bilaterally following the protocol of the German Network on Neuropathic Pain.
• Nerve conduction studies (NCS)
NCS were performed with patients only.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ruhr University of Bochum

Outcome
Type Measure Description Time frame Safety issue
Primary N1-latency N1-latency of pain-related evoked potentials in ms 1 day
Secondary N1P1-amplitude Amplitude of pain-related evoked potentials in µV 1 day
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04572906 - Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries Phase 2
Active, not recruiting NCT03999424 - Autologous Human Schwann Cells in Peripheral Nerve Repair Phase 1
Not yet recruiting NCT05848778 - Non-invasive Therapy to Drive Nerve Regeneration N/A
Completed NCT02070367 - Somatosensory Assessment and Rehabilitation of Allodynia (SARA) N/A
Recruiting NCT03205124 - The Effect of Pre-operative Electrical Stimulation on Peripheral Nerve Regeneration. Phase 2/Phase 3
Recruiting NCT01526681 - Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction
Recruiting NCT03422107 - Somatosensory Evoked Potential (SSEP) Monitoring for Detection of Intraoperative Positional Neuropraxia N/A
Active, not recruiting NCT05339594 - REINVENT Registry (Registry of the Nerve Gap Repair From Integra)
Completed NCT02437695 - Robot Assisted Radical Prostatecomy and Positional Injury N/A
Completed NCT02786888 - Prospective Comparison of Adductor Canal Block Performed With a Multiport Versus Single Bevel Needle N/A
Completed NCT01954199 - The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain N/A
Withdrawn NCT02095899 - Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome Phase 2
Recruiting NCT02403661 - Electrical Stimulation to Enhance Peripheral Nerve Regeneration N/A
Completed NCT03191032 - Early Sensory Re-education of the Hand With a Sensor Glove Model N/A
Recruiting NCT06209801 - Mirror Therapy Integrated With Electrical Stimulation for Cortical Modulations N/A
Recruiting NCT03913689 - StimRouter Registry Clinical Protocol
Terminated NCT02459015 - Performance Study of an Artificial Nerve Guide (Reaxon® Nerve Guide) to Treat Digital Nerve Lesions N/A
Recruiting NCT03780855 - Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold N/A
Recruiting NCT05884125 - Promoting Healing of Injured Nerves With Electrical Stimulation Therapy N/A
Recruiting NCT04789044 - Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion) Phase 2