Psychological Evaluation After SCS Implantation

Quality of Life Clinical Trial

Official title:

Long-term Psychological Evaluation of Patients With Implanted Spinal Cord Stimulator

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05624814
• Other study ID #: Psico-SCS
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University Magna Graecia
• Contact: Federico Longhini, MD
• Phone: +393475395967
• Email: longhini.federico[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• consent denied

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Psychological Disability
• Quality of Life

Intervention

Device:
• Spinal Cord Stimulation
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.

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

Locations

Country	Name	City	State
Italy	AOU Mater Domini	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Metacognition - Memory Assessment Clinics-Questionnaire	the Memory Assessment Clinics-Questionnaire (MAC-Q) assesses the subjective perception of one's memory performance in daily life compared to the past (for this study, reference will be made before the intervention). It consists of 6 items that assess the subject's ability to remember various information (e.g., phone numbers/postal codes used, location of objects). Each item is measured on a 5-point Likert scale (from ''much better now'' to ''much worse now''). The MAC-Q total score ranges from 7 to 35, with higher scores indicating a greater presence of subjective memory complaints.	At patient's inclusion
Secondary	Metacognition - Multifactorial Memory Questionnaire	Multifactorial Memory Questionnaire is a self-administered questionnaire that includes 57 items assessing the three dimensions of metamemory: Satisfaction, Ability, and Strategy.	At patient's inclusion
Secondary	Metacognition - Adult Executive Functioning Inventory	The Adult Executive Functioning Inventory (ADEXI; Holst and Thorell, 2018) is a self-administered questionnaire comprising 14 items that assess subjective perceptions of one's inhibition skills and working memory. Each item is measured on a 5-point Likert scale (from ''definitely not true'' to ''definitely true''). The ADEXI total score ranges from 14 to 70, with higher scores indicating greater subjective impairment in the executive domain.	At patient's inclusion
Secondary	Quality of life	Quality of Life Assessment Questionnaire (Short Form Health Survey 36, SF-36), which consists of a survey of the patient's health status. It is a 36-item scale, which measures eight domains of health status: physical functioning; physical role limitations; bodily pain; general health perceptions; energy/vitality; social functioning; emotional role limitations and mental health. A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. In addition, it is possible to calculate the values of the two synthetic indices, one related to Physical Health (FHH), and the second to Mental Health (MHSI). The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.	At patient's inclusion
Secondary	Behavioral Symptomatology - Beck Depression Inventory	The Beck Depression Inventory (BDI) is a self-report instrument to assess the severity of depression. It consists of 21 items, which assess the presence and intensity of depressive symptoms in the past two weeks, which can be assigned 0 to 3 points. The BDI total score ranges from 0 to 63. The cut-off is equal to 16.	At patient's inclusion
Secondary	Behavioral Symptomatology - State-Trait Anxiety Inventory	The State-Trait Anxiety Inventory (Spielberg et al., 1968) is a self-report instrument to assess the severity of anxiety symptoms. It consists of two scales (Y1 and Y2) of 20 items, which assess state anxiety, through questions referring to how the subject feels at the time of questionnaire administration, and trait anxiety, with questions investigating how the subject habitually feels. The scores for the individual scales range from 20 to 80 with a threshold value predictive of anxiety symptomatology placed at 40.	At patient's inclusion
Secondary	Behavioral Symptomatology - Apathy Evaluation Scale	The Apathy Evaluation Scale (Marin et al., 1991) is a rating scale to assess apathy consisting of 18 items. The total apathy score ranges from 18 to 72 and is given by the sum of the scores obtained at the items assessing cognitive apathy, behavioral apathy, emotional apathy, and items that are part of the other category. The cut-off is equal to 38.	At patient's inclusion
Secondary	Pain - Numeric Rating Scale	The Numeric Rating Scale is an 11-point unidimensional scale that rates pain intensity. The scale consists of a horizontal line, with a range from 0 to 10, corresponding to "no pain" and "worst pain imaginable," respectively. The total score ranges from 0 to 10, with a high score indicating the presence of a greater intensity of pain.	At patient's inclusion
Secondary	Disability - Roland Morris Disability Questionnaire	The Roland Morris Disability Questionnaire is a self-administered questionnaire that assesses the patient's disability and limitations in daily life. It consists of 24 items that assess the subject's ability to perform the 24 listed activities. For each item, a score can be given ranging from 0 (that activity is not limited) to 1 (that activity is limited). The total score ranges from 0 to 24, with high scores indicating the presence of a greater disability.	At patient's inclusion
Secondary	Pain and disability - Pain Catastrophizing Scale	The Pain Catastrophizing Scale is a scale that assesses catastrophic thinking in relation to pain. It consists of 13 items in which participants are asked to reflect on past painful experiences and to indicate how often certain thoughts and feelings occur when they experience pain. Each item can be given a score ranging from 0 (never) to 4 (always). The total score ranges from 0 to 52, with higher scores indicating a greater presence of catastrophic thoughts.	At patient's inclusion
Secondary	Resilience, Perceived Self-efficacy, and Coping Styles - Brief Resilience Scale	The Brief Resilience Scale (BRS) is a self-administered scale that assesses resilience in stressful situations through 6 items on a 5-point Likert scale (1=completely disagree; 2=disagree; 3=neither agree nor disagree; 4=agree; 5=completely agree). The total score ranges from 6 to 30, with higher scores indicating greater resilience in stressful situations.	At patient's inclusion
Secondary	Resilience, Perceived Self-efficacy, and Coping Styles - Pain Self-Efficacy Questionnaire	The Pain Self-Efficacy Questionnaire is a questionnaire used to measure perceived self-efficacy with respect to the presence of pain. It consists of 10 items that describe different daily activities (e.g., I can do most housework) or general aspects of life (e.g., I can still accomplish most of my goals). For each item, the subject must indicate how confident he or she feels that can perform these activities despite the presence of pain. The items are measured on a 7-point Likert scale ranging from 0 (not at all confident) to 6 (completely confident). The total score on the questionnaire can range from 0 to 60, with higher scores indicating greater self-efficacy.	At patient's inclusion
Secondary	Resilience, Perceived Self-efficacy, and Coping Styles - Coping Scale	The Coping Scale is a self-administered questionnaire that assesses the use of cognitive, emotional, and behavioral strategies in problem situations. The questionnaire consists of 13 items measured on a 4-point Likert scale (1=not at all; 2=little; 3=somewhat; 4=very much). Scores range from 13 to 52, with higher scores indicating greater levels of coping strategies.	At patient's inclusion
Secondary	Interoception - Heartbeat Detection Task	Heartbeat Detection Task will be used to investigate interoceptive accuracy. In this task, participants will be asked to count their heartbeats silently only in their minds, without trying to sense their own pulse or heartbeat. They will be asked to wear a wristwatch for objective measurement of heart rate. Three counting phases of 25 sec, 45 sec, and 65 sec durations, interspersed with 30 sec rest, will be carried out and repeated twice. The order of the phases will be randomized. The level of agreement between measured heart rate and reported subjective perception will be considered a relatively reliable characteristic of "interoceptive accuracy."	At patient's inclusion
Secondary	Interoception - Self Awareness Questionnaire	The Self Awareness Questionnaire will be used to investigate interoceptive sensitivity. It consists of 35 items measured on a five-point Likert scale (0 = never to 4 = always). The total score is the sum of all items and ranges from 0 to 140. Higher scores indicate higher levels of interoceptive awareness.	At patient's inclusion
Secondary	Interoceptive awareness	Interoceptive awareness will be investigated using a self-report measure that assesses the individual perception of the degree of accuracy of perceived interoceptive (cardiac) information. The relationship between objective interoceptive accuracy and subjective assessment of one's interoceptive accuracy is calculated to obtain a metacognitive measure of how the perceived degree of interoceptive accuracy corresponds to objectively measured interoceptive accuracy.	At patient's inclusion