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Psychological DisabilityNCT05624814

Psychological Evaluation After SCS Implantation

An observational study of Psychological Disability and Cognitive Impairment, run by University Magna Graecia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Spinal Cord Stimulation and Standard therapies
Type of treatment
Medical device
How many people
60 participants
Where
1 siteItaly
Study dates
1 Jan 2023to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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).

Who cannot join

  • consent denied

Trial locations and contacts

1 site in 1 country.

Federico Longhini, MD contact

+393475395967

longhini.federico@gmail.com

Italy1 site
  • AOU Mater Domini

    Catanzaro

Other trials in Italy

About this study

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

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.

Being tested
Spinal Cord Stimulation, Standard therapies
Keywords
Spinal Cord Stimulation, Psychological Disability, Cognitive Impairment, Quality of Life, Metacognition, Pain and Disability
Medical subject headings
Cognitive Dysfunction, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal Cord StimulationDevice

    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.

  • Standard therapiesOther

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

Study groups in NCT05624814
Study groupRoleWhat they receive
Experimental groupPatients with chronic pain which failed standard therapies and with an implanted Spinal Cord Stimulator
Receives: Device: Spinal Cord Stimulation
Comparison groupPatients with chronic pain following traditional therapies, i.e. pharmacological, psychological, physical and occupational therapies or surgery.
Receives: Other: Standard therapies
Control groupHealthy volunteers matched for age and schooling to those included in the experimental group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At patient's inclusion

  2. 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.

    Measured: At patient's inclusion

Secondary outcomes (16)
  1. 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.

    Measured: At patient's inclusion

  2. 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.

    Measured: At patient's inclusion

  3. 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.

    Measured: At patient's inclusion

  4. 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.

    Measured: At patient's inclusion

  5. 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.

    Measured: At patient's inclusion

  6. 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.

    Measured: At patient's inclusion

  7. 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.

    Measured: At patient's inclusion

  8. 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.

    Measured: At patient's inclusion

  9. 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.

    Measured: At patient's inclusion

  10. 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.

    Measured: At patient's inclusion

  11. 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.

    Measured: At patient's inclusion

  12. 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.

    Measured: At patient's inclusion

  13. 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.

    Measured: At patient's inclusion

  14. 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."

    Measured: At patient's inclusion

  15. 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.

    Measured: At patient's inclusion

  16. 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.

    Measured: At patient's inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2022
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05624814
Sponsor's protocol ID
Psico-SCS
Status last verified
Nov 2022
First submitted
14 Nov 2022
Last updated
22 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymous data will be shared with al researchers after publication, on reasonable scientific request to the Principal Investigator

Questions about this trial

What is this clinical trial studying?

An observational study of Psychological Disability and Cognitive Impairment, run by University Magna Graecia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Federico Longhini, MD (+393475395967, longhini.federico@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Cognitive Functioning - Montreal Cognitive Assessment (time frame: At patient's inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.

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