Chronic PainNCT06587919
Improving Dysregulated Neural Networks With EEG-neurofeedback
A study testing Neurofeedback in people with Chronic Pain and Ptsd, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Comorbid PTSD in the context of chronic pain rehabilitation is a major problem. The lack of effective and efficient methods that can be integrated into current practice is needed. The current recommended treatments for PTSD leave room for supplementary approaches to achieve symptom reduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Ptsd
- What is being tested?
- Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Sep 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- has finished treatment at Smertecenter Syd.
- is still experiencing pain of more than 4 on the Numeric Ranking Scale (NRS).
- has been exposed to an adverse event that causes continued arousal according to the International Trauma Questionnaire.
Who cannot join
- Participants with known neurological disorders will be excluded from participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Dysregulated Neural Networks With EEG-neurofeedback - A Randomized Placebo-Controlled Study
Comorbid PTSD in the context of chronic pain rehabilitation is a major problem. The lack of effective and efficient methods that can be integrated into current practice is needed. The current recommended treatments for PTSD leave room for supplementary approaches to achieve symptom reduction. PTSD is characterized by specific alterations of neural activity, and the DMN is known to be involved in this. Neurofeedback is the most current approach to altering neural activity patterns towards a norm pattern found in healthy subjects.
The aim of the present study is to assess whether EEG neurofeedback compared to an active control group receiving EEG sham neurofeedback is effective in alleviating PTSD symptoms and pain intensity in patients with chronic pain and comorbid PTSD after MVCs.
Read the detailed description
Prevalence and current treatment of PTSD PTSD is a debilitating mental health disorder arising from exposure to traumatic events such as war, motor vehicle accidents, crimes, and other events, threatening the lives of oneself or others involved.
The current recommended treatments for PTSD victims consist of psychotherapies and pharmacological interventions. Although 60% of PTSD patients experience improvements from a variety of trauma-focused cognitive behavior therapies, and pharmacotherapies, as many as 40% of PTSD patients do not experience symptom relief from existent therapies. Thus, the development of novel treatment alternatives is needed.
Injuries related to motor vehicle crashes (MVC) are one of the major causes of morbidity and mortality in the Western world. While physical injury and pain are the primary symptoms after MVC, between 20-40% also experience severe posttraumatic stress disorder symptoms. What is less known is that psychological distress is higher among those who have sustained a minor injury, such as whiplash injury, compared to more severe injuries, such as spinal cord injury. In particular PTSD symptoms such as hyperarousal are common after MVCs and an important mechanism in the development of chronic pain and disability after MVCs. With the mutual maintenance theory, it is suggested that pain and PTSD are mutually maintaining conditions. Indeed, PTSD is highly prevalent in the context of chronic pain rehabilitation of victims of MVCs with about 20% experiencing severe PTSD symptoms. Those with high levels of PTSD symptoms are known to experience higher levels of pain, disability, and distress. Unfortunately, targeting PTSD in pain rehabilitation is uncommon and the few existing trials that have tried to target comorbid PTSD and pain have not been sufficiently effective in alleviating pain and PTSD symptoms. Treatment resistance may be due to dysregulated brain networks that are not sufficiently targeted with traditional psychotherapeutic approaches.
A novel and promising method to target PTSD is source-localized EEG neurofeedback in that this method targets specific neural regions; thus, the treatment can be tailored to the individual patient's symptoms. As the treatment is entirely noninvasive and low-cost, the potential and the feasibility that the neurofeedback method can be employed broadly and that patients can train in between treatment sessions is considerable.
Here, we propose an investigation of the potential of standardized weighted Low-Resolution Tomography EEG neurofeedback training in treatment of comorbid PTSD in chronic pain. Our proposed study investigates the neural mechanisms hypothesized to be involved in neurofeedback training for PTSD patients. By testing, if such training can alter activity in specific target neural regions related to PTSD symptoms in our patient group, the goal is to evaluate the technique as a supplement to current therapies. We compare the active EEG neurofeedback treatment with a placebo control condition receiving sham EEG neurofeedback.
Neurofeedback In its most basic form, neurofeedback is a non-invasive technique, in which a person is trained to regulate his/her own neural activity. For psychological symptoms which are linked to dysregulated neural activity, neurofeedback may offer symptom alleviation by teaching patients to regulate relevant activity patterns themselves. By rewarding the person whenever the neural activity changes in a desired direction, the activity can be regulated or modulated. The pivotal mechanism is thus operant conditioning: A desired change in neural activity is followed by a rewarding stimulus as positive reinforcement. This reward may be appetitive to the patient, or, the reward may be in the form of a signal notifying that the training criterion is met, which in itself may be rewarding for a patient seeking symptom alleviation.
Since the 1990s, a number of studies have reported positive treatment outcomes for neurofeedback in psychiatric disorders establishing the value of neurofeedback interventions within mainstream psychiatry. Our proposed study aims at systematically registering the mechanisms involved in neurofeedback when applied to patients with comorbid PTSD and chronic pain. By doing so, we aim at furthering our understanding of the neural structures involved in posttraumatic stress symptoms and chronic pain and how neurofeedback may alter their activity patterns. This knowledge will enable the design of a specific and optimized neurofeedback training protocol for patients with PTSD and chronic pain after MVCs.
In recent decades, large-scale studies of EEG in healthy subjects across all ages and genders have been conducted to create knowledge on the characteristics of the human EEG. Such data have been processed and stored in databases making a wide range of EEG parameters available as norm data. EEG in a patient can thus be analyzed in terms of deviations from such norms. Deviations along some EEG parameters, which may be hypothesized to be involved in the targeted symptoms, can then be trained via neurofeedback to achieve greater congruence with relevant EEG parameters in healthy subjects.
Traditional neurofeedback uses one or two electrodes on the head to increase or decrease activity within a particular frequency band. Standardized Weighted Low Resolution Electromagnetic Tomography (swLORETA) is a mathematical technique to analyze the three-dimensional distribution of intracortical brain electrical activity based on surface EEG recordings. The computation enables imaging of real-time brainwave activity with a spatial resolution of less than one cubic centimeter as it divides the brain into over 12,000 voxels or pieces; this provides localization similar to that of fMRI while preserving the faster temporal resolutions of EEG. Thus, while traditional neurofeedback protocols typically utilize one or two electrode sites to train diffuse brainwave frequencies near the outer surface of the brain, source localized NF can more directly target specific brain regions even deeper within the cortex. It can also target multiple Brodmann areas simultaneously as well as give feedback on connectivity or communication between different neural sources (coherence and phase relations), enabling the option to train specific neural networks.
In combination, state-of-the-art neurofeedback offers training in deviating neural activity towards a norm mean recorded in healthy subjects, specifically targeting anatomical regions involved in symptoms.
Altered neurocircuitry in PTSD Due to the nature of the diagnostic criteria, PTSD is a heterogeneous disorder with symptom levels varying across symptom clusters. However, a key observation is changes in hyperarousal as well as self-referential processing, which refers to information relevant to oneself and is an essential component in cognitive processing. Furthermore, PTSD patients may report changes in somatic self-reference and self-perception.
In recent years, neuroscientific research has shown that many psychiatric disorders can be understood as disturbances within, or, in the relation between three basic, large brain networks. The default mode network (DMN), the salience network (SN), and the central executive networks (CEN) are concerned with self-referential processing, with external, task-related processing and with executive functions respectively. Changes in the functioning or connectivity within one network propagate to the remaining two.
Symptoms of disturbed self-referential processing in PTSD have been linked to changes in DMN connectivity. Changes in DMN may further be accompanied by an increase in SN activity, resulting in hyperarousal/heightened threat perception, and a decrease in CEN activity. Recently, PTSD symptomatology has been shown to be predicted by the level of DMN disturbance. Alterations in DMN activity and connectivity are thus strong candidates for neural correlates to altered self-referential processing in PTSD and the symptoms associated with this. Based on this knowledge, a restoration of normal activity in the DMN through neurofeedback has been suggested as a viable supplement to current treatments.
Alterations in DMN activity have also been found in acute and chronic pain states, which may reflect underlying alterations in attentional processes associated with the presence of pain itself as it has been reported that chronic pain patients also display significant attention and mental flexibility deficits. In fact, multiple studies have reported significant changes in DMN function in many chronic pain conditions. It has been suggested that the strength of the functional connections between brain regions within the DMN in chronic pain subjects relates to pain rumination, which is a measure of an individual's continuous focus on pain and its potential negative outcomes.
- Conditions
- Chronic Pain, Ptsd
- Being tested
- Neurofeedback
- Keywords
- EEG, neurofeedback, pain, ptsd
- Medical subject headings
- Chronic Pain, Stress Disorders, Post-Traumatic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackDevice
EEG-based neurofeedback, administered with the Neuroguide software.
| Study group | Role | What they receive |
|---|---|---|
| Real EEG-NF | Active comparator | 10 EEG based neurofeedback sessions modulating the activity of the default mode network. Receives: Device: Neurofeedback |
| Sham EEG-NF | Sham comparator | 10 sessions of neurofeedback another person's EEG. Receives: Device: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity rating
Average pain intensity during the last day and current pain intensity before beginning the neurofeedback session, will be assessed on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: Before every nf-session and six months after the last session.
EEG-power in alpha band
37-channel EEG will be recorded, the alpha power seems to indicate cortical activity.
Measured: Before the first nf-session and after the last session (roughly six weeks later)
Secondary outcomes (1)
General QoL
World Health Organization Quality of Life (WHOQOL)-Brief contains questions about how the subject feels in their everyday life, most answers are given on a five-point scale with 1 being worst/least and 5 being best/most.
Measured: Assessed before first nf-session, after five weeks and after seven months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 Sep 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Imaging future
- Responsible party
- Sponsor
- Investigators
- Tonny Elmose Andersen, PhD, Principal investigator, Professor at Institute of Psychology, SDU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587919
- Sponsor's protocol ID
- 93533245
- Status last verified
- Nov 2024
- First submitted
- 29 Aug 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sterling M, Hendrikz J, Kenardy J, Kristjansson E, Dumas JP, Niere K, Cote J, deSerres S, Rivest K, Jull G. Assessment and validation of prognostic models for poor functional recovery 12 months after whiplash injury: a multicentre inception cohort study. Pain. 2012 Aug;153(8):1727-1734. doi: 10.1016/j.pain.2012.05.004. Epub 2012 Jun 1.
PubMed 22658881Siqveland J, Hussain A, Lindstrom JC, Ruud T, Hauff E. Prevalence of Posttraumatic Stress Disorder in Persons with Chronic Pain: A Meta-analysis. Front Psychiatry. 2017 Sep 14;8:164. doi: 10.3389/fpsyt.2017.00164. eCollection 2017.
PubMed 28959216Sharp TJ, Harvey AG. Chronic pain and posttraumatic stress disorder: mutual maintenance? Clin Psychol Rev. 2001 Aug;21(6):857-77. doi: 10.1016/s0272-7358(00)00071-4.
PubMed 11497210Ravn SL, Hartvigsen J, Hansen M, Sterling M, Andersen TE. Do post-traumatic pain and post-traumatic stress symptomatology mutually maintain each other? A systematic review of cross-lagged studies. Pain. 2018 Nov;159(11):2159-2169. doi: 10.1097/j.pain.0000000000001331.
PubMed 29994992Ipser J, Seedat S, Stein DJ. Pharmacotherapy for post-traumatic stress disorder - a systematic review and meta-analysis. S Afr Med J. 2006 Oct;96(10):1088-96.
PubMed 17164942Craig A, Tran Y, Guest R, Gopinath B, Jagnoor J, Bryant RA, Collie A, Tate R, Kenardy J, Middleton JW, Cameron I. Psychological impact of injuries sustained in motor vehicle crashes: systematic review and meta-analysis. BMJ Open. 2016 Sep 8;6(9):e011993. doi: 10.1136/bmjopen-2016-011993.
PubMed 27609849Buitenhuis J, de Jong PJ, Jaspers JP, Groothoff JW. Relationship between posttraumatic stress disorder symptoms and the course of whiplash complaints. J Psychosom Res. 2006 Nov;61(5):681-9. doi: 10.1016/j.jpsychores.2006.07.008.
PubMed 17084147Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214.
PubMed 15677582Andersen TE, Ravn SL, Armfield N, Maujean A, Requena SS, Sterling M. Trauma-focused cognitive behavioural therapy and exercise for chronic whiplash with comorbid posttraumatic stress disorder: a randomised controlled trial. Pain. 2021 Apr 1;162(4):1221-1232. doi: 10.1097/j.pain.0000000000002117.
PubMed 33086286Andersen TE, Lahav Y, Ellegaard H, Manniche C. A randomized controlled trial of brief Somatic Experiencing for chronic low back pain and comorbid post-traumatic stress disorder symptoms. Eur J Psychotraumatol. 2017 May 30;8(1):1331108. doi: 10.1080/20008198.2017.1331108. eCollection 2017.
PubMed 28680540Andersen TE, Ellegaard H, Schiottz-Christensen B, Mejldal A, Manniche C. Somatic Experiencing(R) for patients with low back pain and comorbid posttraumatic stress symptoms - a randomised controlled trial. Eur J Psychotraumatol. 2020 Aug 18;11(1):1797306. doi: 10.1080/20008198.2020.1797306.
PubMed 33029333
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Dysregulated Neural Networks With EEG-neurofeedback - A Randomized Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06587919
- Acronym / sponsor ID
- 93533245
- Conditions
- Chronic Pain, Ptsd
- Keywords
- EEG, neurofeedback, pain, ptsd
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Imaging future
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Comorbid PTSD in the context of chronic pain rehabilitation is a major problem. The lack of effective and efficient methods that can be integrated into current practice is needed. The current recommended treatments for PTSD leave room for supplementary approaches to achieve symptom reduction. PTSD is characterized by specific alterations of neural activity, and the DMN is known to be involved in this. Neurofeedback is the most current approach to altering neural activity patterns towards a norm pattern found in healthy subjects.
The aim of the present study is to assess whether EEG neurofeedback compared to an active control group receiving EEG sham neurofeedback is effective in alleviating PTSD symptoms and pain intensity in patients with chronic pain and comorbid PTSD after MVCs.
Detailed description
Prevalence and current treatment of PTSD PTSD is a debilitating mental health disorder arising from exposure to traumatic events such as war, motor vehicle accidents, crimes, and other events, threatening the lives of oneself or others involved.
The current recommended treatments for PTSD victims consist of psychotherapies and pharmacological interventions. Although 60% of PTSD patients experience improvements from a variety of trauma-focused cognitive behavior therapies, and pharmacotherapies, as many as 40% of PTSD patients do not experience symptom relief from existent therapies. Thus, the development of novel treatment alternatives is needed.
Injuries related to motor vehicle crashes (MVC) are one of the major causes of morbidity and mortality in the Western world. While physical injury and pain are the primary symptoms after MVC, between 20-40% also experience severe posttraumatic stress disorder symptoms. What is less known is that psychological distress is higher among those who have sustained a minor injury, such as whiplash injury, compared to more severe injuries, such as spinal cord injury. In particular PTSD symptoms such as hyperarousal are common after MVCs and an important mechanism in the development of chronic pain and disability after MVCs. With the mutual maintenance theory, it is suggested that pain and PTSD are mutually maintaining conditions. Indeed, PTSD is highly prevalent in the context of chronic pain rehabilitation of victims of MVCs with about 20% experiencing severe PTSD symptoms. Those with high levels of PTSD symptoms are known to experience higher levels of pain, disability, and distress. Unfortunately, targeting PTSD in pain rehabilitation is uncommon and the few existing trials that have tried to target comorbid PTSD and pain have not been sufficiently effective in alleviating pain and PTSD symptoms. Treatment resistance may be due to dysregulated brain networks that are not sufficiently targeted with traditional psychotherapeutic approaches.
A novel and promising method to target PTSD is source-localized EEG neurofeedback in that this method targets specific neural regions; thus, the treatment can be tailored to the individual patient's symptoms. As the treatment is entirely noninvasive and low-cost, the potential and the feasibility that the neurofeedback method can be employed broadly and that patients can train in between treatment sessions is considerable.
Here, we propose an investigation of the potential of standardized weighted Low-Resolution Tomography EEG neurofeedback training in treatment of comorbid PTSD in chronic pain. Our proposed study investigates the neural mechanisms hypothesized to be involved in neurofeedback training for PTSD patients. By testing, if such training can alter activity in specific target neural regions related to PTSD symptoms in our patient group, the goal is to evaluate the technique as a supplement to current therapies. We compare the active EEG neurofeedback treatment with a placebo control condition receiving sham EEG neurofeedback.
Neurofeedback In its most basic form, neurofeedback is a non-invasive technique, in which a person is trained to regulate his/her own neural activity. For psychological symptoms which are linked to dysregulated neural activity, neurofeedback may offer symptom alleviation by teaching patients to regulate relevant activity patterns themselves. By rewarding the person whenever the neural activity changes in a desired direction, the activity can be regulated or modulated. The pivotal mechanism is thus operant conditioning: A desired change in neural activity is followed by a rewarding stimulus as positive reinforcement. This reward may be appetitive to the patient, or, the reward may be in the form of a signal notifying that the training criterion is met, which in itself may be rewarding for a patient seeking symptom alleviation.
Since the 1990s, a number of studies have reported positive treatment outcomes for neurofeedback in psychiatric disorders establishing the value of neurofeedback interventions within mainstream psychiatry. Our proposed study aims at systematically registering the mechanisms involved in neurofeedback when applied to patients with comorbid PTSD and chronic pain. By doing so, we aim at furthering our understanding of the neural structures involved in posttraumatic stress symptoms and chronic pain and how neurofeedback may alter their activity patterns. This knowledge will enable the design of a specific and optimized neurofeedback training protocol for patients with PTSD and chronic pain after MVCs.
In recent decades, large-scale studies of EEG in healthy subjects across all ages and genders have been conducted to create knowledge on the characteristics of the human EEG. Such data have been processed and stored in databases making a wide range of EEG parameters available as norm data. EEG in a patient can thus be analyzed in terms of deviations from such norms. Deviations along some EEG parameters, which may be hypothesized to be involved in the targeted symptoms, can then be trained via neurofeedback to achieve greater congruence with relevant EEG parameters in healthy subjects.
Traditional neurofeedback uses one or two electrodes on the head to increase or decrease activity within a particular frequency band. Standardized Weighted Low Resolution Electromagnetic Tomography (swLORETA) is a mathematical technique to analyze the three-dimensional distribution of intracortical brain electrical activity based on surface EEG recordings. The computation enables imaging of real-time brainwave activity with a spatial resolution of less than one cubic centimeter as it divides the brain into over 12,000 voxels or pieces; this provides localization similar to that of fMRI while preserving the faster temporal resolutions of EEG. Thus, while traditional neurofeedback protocols typically utilize one or two electrode sites to train diffuse brainwave frequencies near the outer surface of the brain, source localized NF can more directly target specific brain regions even deeper within the cortex. It can also target multiple Brodmann areas simultaneously as well as give feedback on connectivity or communication between different neural sources (coherence and phase relations), enabling the option to train specific neural networks.
In combination, state-of-the-art neurofeedback offers training in deviating neural activity towards a norm mean recorded in healthy subjects, specifically targeting anatomical regions involved in symptoms.
Altered neurocircuitry in PTSD Due to the nature of the diagnostic criteria, PTSD is a heterogeneous disorder with symptom levels varying across symptom clusters. However, a key observation is changes in hyperarousal as well as self-referential processing, which refers to information relevant to oneself and is an essential component in cognitive processing. Furthermore, PTSD patients may report changes in somatic self-reference and self-perception.
In recent years, neuroscientific research has shown that many psychiatric disorders can be understood as disturbances within, or, in the relation between three basic, large brain networks. The default mode network (DMN), the salience network (SN), and the central executive networks (CEN) are concerned with self-referential processing, with external, task-related processing and with executive functions respectively. Changes in the functioning or connectivity within one network propagate to the remaining two.
Symptoms of disturbed self-referential processing in PTSD have been linked to changes in DMN connectivity. Changes in DMN may further be accompanied by an increase in SN activity, resulting in hyperarousal/heightened threat perception, and a decrease in CEN activity. Recently, PTSD symptomatology has been shown to be predicted by the level of DMN disturbance. Alterations in DMN activity and connectivity are thus strong candidates for neural correlates to altered self-referential processing in PTSD and the symptoms associated with this. Based on this knowledge, a restoration of normal activity in the DMN through neurofeedback has been suggested as a viable supplement to current treatments.
Alterations in DMN activity have also been found in acute and chronic pain states, which may reflect underlying alterations in attentional processes associated with the presence of pain itself as it has been reported that chronic pain patients also display significant attention and mental flexibility deficits. In fact, multiple studies have reported significant changes in DMN function in many chronic pain conditions. It has been suggested that the strength of the functional connections between brain regions within the DMN in chronic pain subjects relates to pain rumination, which is a measure of an individual's continuous focus on pain and its potential negative outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real EEG-NF | Active comparator | Device: Neurofeedback10 EEG based neurofeedback sessions modulating the activity of the default mode network. |
| Sham EEG-NF | Sham comparator | Device: Neurofeedback10 sessions of neurofeedback another person's EEG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- has finished treatment at Smertecenter Syd.
- is still experiencing pain of more than 4 on the Numeric Ranking Scale (NRS).
- has been exposed to an adverse event that causes continued arousal according to the International Trauma Questionnaire.
Key exclusion criteria (1 listed)
- Participants with known neurological disorders will be excluded from participation.
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 |
|---|---|---|
| NeurofeedbackEEG-based neurofeedback, administered with the Neuroguide software. | Device | Real EEG-NF, Sham EEG-NF |
Primary outcome
Pain intensity rating
Time frame: Before every nf-session and six months after the last session.
Average pain intensity during the last day and current pain intensity before beginning the neurofeedback session, will be assessed on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain)
EEG-power in alpha band
Time frame: Before the first nf-session and after the last session (roughly six weeks later)
37-channel EEG will be recorded, the alpha power seems to indicate cortical activity.
1 secondary outcome
General QoL
Time frame: Assessed before first nf-session, after five weeks and after seven months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 22658881Sterling M, Hendrikz J, Kenardy J, Kristjansson E, Dumas JP, Niere K, Cote J, deSerres S, Rivest K, Jull G. Assessment and validation of prognostic models for poor functional recovery 12 months after whiplash injury: a multicentre inception cohort study. Pain. 2012 Aug;153(8):1727-1734. doi: 10.1016/j.pain.2012.05.004. Epub 2012 Jun 1.
- Background: PubMed 28959216Siqveland J, Hussain A, Lindstrom JC, Ruud T, Hauff E. Prevalence of Posttraumatic Stress Disorder in Persons with Chronic Pain: A Meta-analysis. Front Psychiatry. 2017 Sep 14;8:164. doi: 10.3389/fpsyt.2017.00164. eCollection 2017.
- Background: PubMed 11497210Sharp TJ, Harvey AG. Chronic pain and posttraumatic stress disorder: mutual maintenance? Clin Psychol Rev. 2001 Aug;21(6):857-77. doi: 10.1016/s0272-7358(00)00071-4.
- Background: PubMed 29994992Ravn SL, Hartvigsen J, Hansen M, Sterling M, Andersen TE. Do post-traumatic pain and post-traumatic stress symptomatology mutually maintain each other? A systematic review of cross-lagged studies. Pain. 2018 Nov;159(11):2159-2169. doi: 10.1097/j.pain.0000000000001331.
- Background: PubMed 17164942Ipser J, Seedat S, Stein DJ. Pharmacotherapy for post-traumatic stress disorder - a systematic review and meta-analysis. S Afr Med J. 2006 Oct;96(10):1088-96.
- Background: PubMed 27609849Craig A, Tran Y, Guest R, Gopinath B, Jagnoor J, Bryant RA, Collie A, Tate R, Kenardy J, Middleton JW, Cameron I. Psychological impact of injuries sustained in motor vehicle crashes: systematic review and meta-analysis. BMJ Open. 2016 Sep 8;6(9):e011993. doi: 10.1136/bmjopen-2016-011993.
- Background: PubMed 17084147Buitenhuis J, de Jong PJ, Jaspers JP, Groothoff JW. Relationship between posttraumatic stress disorder symptoms and the course of whiplash complaints. J Psychosom Res. 2006 Nov;61(5):681-9. doi: 10.1016/j.jpsychores.2006.07.008.
- Background: PubMed 15677582Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214.
- Background: PubMed 33086286Andersen TE, Ravn SL, Armfield N, Maujean A, Requena SS, Sterling M. Trauma-focused cognitive behavioural therapy and exercise for chronic whiplash with comorbid posttraumatic stress disorder: a randomised controlled trial. Pain. 2021 Apr 1;162(4):1221-1232. doi: 10.1097/j.pain.0000000000002117.
- Background: PubMed 28680540Andersen TE, Lahav Y, Ellegaard H, Manniche C. A randomized controlled trial of brief Somatic Experiencing for chronic low back pain and comorbid post-traumatic stress disorder symptoms. Eur J Psychotraumatol. 2017 May 30;8(1):1331108. doi: 10.1080/20008198.2017.1331108. eCollection 2017.
- Background: PubMed 33029333Andersen TE, Ellegaard H, Schiottz-Christensen B, Mejldal A, Manniche C. Somatic Experiencing(R) for patients with low back pain and comorbid posttraumatic stress symptoms - a randomised controlled trial. Eur J Psychotraumatol. 2020 Aug 18;11(1):1797306. doi: 10.1080/20008198.2020.1797306.
- Individual participant dataSharing planned: No
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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.
Tonny Elmose Andersen, PhD principal investigator
Professor at Institute of Psychology, SDU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Chronic Pain and Ptsd, run by University of Southern Denmark at 1 site in Denmark.
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 3 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: enrolling by invitation, as of the sponsor's last update on 21 Nov 2024. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity rating (time frame: Before every nf-session and six months after the last session.). 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?
On the ClinicalTrials.gov record for NCT06587919, which also lists 11 linked publications.
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 21 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.