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.
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
- Conditions the study is for
- Psychological Disability, Cognitive Impairment, Quality of Life
- 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.
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 group | Role | What they receive |
|---|---|---|
| Experimental group | Patients with chronic pain which failed standard therapies and with an implanted Spinal Cord Stimulator Receives: Device: Spinal Cord Stimulation | |
| Comparison group | Patients with chronic pain following traditional therapies, i.e. pharmacological, psychological, physical and occupational therapies or surgery. Receives: Other: Standard therapies | |
| Control group | Healthy 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.
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted22 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Magna Graecia University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Psychological Evaluation of Patients With Implanted Spinal Cord Stimulator
- ClinicalTrials.gov ID
- NCT05624814
- Acronym / sponsor ID
- Psico-SCS
- Keywords
- Spinal Cord Stimulation, Psychological Disability, Cognitive Impairment, Quality of Life, Metacognition, Pain and Disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Device: Spinal Cord StimulationPatients with chronic pain which failed standard therapies and with an implanted Spinal Cord Stimulator |
| Comparison group | – | Other: Standard therapiesPatients with chronic pain following traditional therapies, i.e. pharmacological, psychological, physical and occupational therapies or surgery. |
| Control group | – | –Healthy volunteers matched for age and schooling to those included in the experimental group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- consent denied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord StimulationSpinal 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. | Device | Experimental group |
| Standard therapiesStandard therapies for chronic low back pain are pharmacological, psychological, physical and occupational therapies or surgery. | Other | Comparison group |
Primary outcome
Global Cognitive Functioning - Montreal Cognitive Assessment
Time frame: At patient's inclusion
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.
Global Cognitive Functioning - Raven's Colored Progressive Matrices Test
Time frame: At patient's inclusion
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.
16 secondary outcomes
Metacognition - Memory Assessment Clinics-Questionnaire
Time frame: At patient's inclusion
Metacognition - Multifactorial Memory Questionnaire
Time frame: At patient's inclusion
Metacognition - Adult Executive Functioning Inventory
Time frame: At patient's inclusion
Quality of life
Time frame: At patient's inclusion
Behavioral Symptomatology - Beck Depression Inventory
Time frame: At patient's inclusion
Behavioral Symptomatology - State-Trait Anxiety Inventory
Time frame: At patient's inclusion
Behavioral Symptomatology - Apathy Evaluation Scale
Time frame: At patient's inclusion
Pain - Numeric Rating Scale
Time frame: At patient's inclusion
Disability - Roland Morris Disability Questionnaire
Time frame: At patient's inclusion
Pain and disability - Pain Catastrophizing Scale
Time frame: At patient's inclusion
Resilience, Perceived Self-efficacy, and Coping Styles - Brief Resilience Scale
Time frame: At patient's inclusion
Resilience, Perceived Self-efficacy, and Coping Styles - Pain Self-Efficacy Questionnaire
Time frame: At patient's inclusion
Resilience, Perceived Self-efficacy, and Coping Styles - Coping Scale
Time frame: At patient's inclusion
Interoception - Heartbeat Detection Task
Time frame: At patient's inclusion
Interoception - Self Awareness Questionnaire
Time frame: At patient's inclusion
Interoceptive awareness
Time frame: At patient's inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Individual participant dataSharing planned: Yes. Anonymous data will be shared with al researchers after publication, on reasonable scientific request to the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Longhini, MD principal investigator
Magna Graecia University
1 site in 1 country: see every site and its status.
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.