Psychological Evaluation After SCS Implantation

NCT05624814 | Unknown

• 1 other identifier: Psico-SCS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord stimulation (SCS) is a therapeutic option for patients with chronic low back pain (CLBP) syndrome, when pharmacological, psychological, physical and occupational therapies or surgery fail to reduce symptoms. CLBP is a common disease with several negative consequences on the quality of life, work and activity ability and increased costs to the health-care system. We have therefore designed this observational study to assess global cognitive functioning in three different groups of patients: patients with chronic pain undergoing intervention (experimental group), patients with chronic pain following traditional therapies (comparison group) and healthy participants matched for age and schooling (healthy subjects). A neuropsychological assessment battery designed to assess global cognitive functioning, behavioral symptomatology, metacognition, quality of life, interoception, pain perception, self-efficacy, and coping styles will be conducted.

Conditions

Psychological Disability; Cognitive Impairment; Quality of Life

Keywords

Spinal Cord Stimulation; Psychological Disability; Cognitive Impairment; Quality of Life; Metacognition; Pain and Disability

Outcome Measures

Primary Outcomes (2)

• Global Cognitive Functioning - Montreal Cognitive Assessment

  Montreal Cognitive Assessment provides screening of global cognitive functioning; it is composed of 12 subtasks exploring: memory; visuospatial abilities assessed by a clock-drawing task and by copying of a cube; executive functions assessed by means of a brief version of the Trail Making B task, a phonemic fluency task, and a two-item verbal abstraction task; attention, concentration and working memory assessed by means of a sustained attention task (target detection using tapping), a serial subtraction task, and forward and backward span tasks for digits; language assessed by a naming task with low-familiarity animals, repetition of two syntactically complex sentences and the above-mentioned phonemic fluency task; temporal and spatial orientation.

  At patient's inclusion

• Global Cognitive Functioning - Raven's Colored Progressive Matrices Test

  The Raven's Colored Progressive Matrices Test assesses abstract reasoning abilities with nonverbal material. The test consists of 36 matrices, grouped into 3 sets of increasing difficulty. Each matrix has a missing piece that the subject must choose from six alternatives available. The total score ranges from 0 to 36 and is obtained by summing the number of correct answers.

  At patient's inclusion

Secondary Outcomes (16)

• Metacognition - Memory Assessment Clinics-Questionnaire

  At patient's inclusion

• Metacognition - Multifactorial Memory Questionnaire

  At patient's inclusion

• Metacognition - Adult Executive Functioning Inventory

  At patient's inclusion

• Quality of life

  At patient's inclusion

• Behavioral Symptomatology - Beck Depression Inventory

  At patient's inclusion

Study Arms (3)

Experimental group

Patients with chronic pain which failed standard therapies and with an implanted Spinal Cord Stimulator

Device: Spinal Cord Stimulation

Comparison group

Patients with chronic pain following traditional therapies, i.e. pharmacological, psychological, physical and occupational therapies or surgery.

Other: Standard therapies

Control group

Healthy volunteers matched for age and schooling to those included in the experimental group

Interventions

Spinal Cord Stimulation DEVICE

Spinal Cord Stimulation consists of the transcutaneous or surgical implantation of different types of electrodes in the epidural space; electrodes are then connected to an Implanted Pulse Generator that generates stimulating currents.

Experimental group

Standard therapies OTHER

Standard therapies for chronic low back pain are pharmacological, psychological, physical and occupational therapies or surgery.

Comparison group

Eligibility Criteria

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

Study Population

60 consecutive patients (20 per cohort) will be enrolled if they meet the inclusion criteria and no exclusion criteria as per cohort.

You may qualify if:

• age greater than 18 years
• presence of chronic pain treated with spinal cord stimulation (Experimental Group)
• presence of chronic pain receiving standard therapies (Comparison Group)
• healthy participants matched for age and schooling (Control Group).

You may not qualify if:

• consent denied

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

AOU Mater Domini

Catanzaro, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Federico Longhini, MD

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Longhini, MD

CONTACT

+393475395967; longhini.federico@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Intensive Care and Anesthesia Department

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After study publication
• Access Criteria: On reasonable scientific request by email the Principal Investigator

Locations

IT (1)