Chronic Pain SyndromeSMR-PainNCT06234917
Increasing Sensori-Motor Rhythm Activity by EEG-Neurofeedback to Reduce the Impact of Pain on Daily Functioning
A study testing EEG-based neurofeedback for brain activity modulation in people with Chronic Pain Syndrome and Peripheral Neuropathic Pain, run by Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy) at 1 site in France.
Trial summary
Background: Chronic neuropathic pain associated with peripheral neuropathies cannot be attributed solely to lesions of peripheral sensory axons and likely involves alteration in the processing of nociceptive information in the central nervous system in most patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain Syndrome, Peripheral Neuropathic Pain
- What is being tested?
- EEG-based neurofeedback for brain activity modulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2021to 1 Feb 2023
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite peripheral neuropathy on both clinical and neurophysiological grounds, present for at least 6 months.
- Neuropathic pain clearly related to the neuropathy, as defined by a score ≥ 4/10 on the DN4 questionnaire.
- Score ≥ 4/10 on a 0-10 numerical rating scale (NRS) concerning the average intensity of daily ongoing pain.
- Age between 18 and 80 years.
- Affiliation with the social security system.
- Ability to provide signed informed consent.
Who cannot join
- Neurological disorder other than peripheral neuropathy (neurodegenerative disorders, migraine, epilepsy, stroke, tumor).
- Psychiatric illness.
- Major visual disturbance.
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Henri Mondor University Hospital
Créteil, Île-de-France Region, 94000
About this study
Official title: Relieving Peripheral Neuropathic Pain by Increasing the Power-ratio of Low-β Over High-β Activities in the Central Cortical Region With EEG-based Neurofeedback: Study Protocol for a Controlled Pilot Trial
Background: Chronic neuropathic pain associated with peripheral neuropathies cannot be attributed solely to lesions of peripheral sensory axons and likely involves alteration in the processing of nociceptive information in the central nervous system in most patients. Few data are available regarding EEG correlates of chronic neuropathic pain. The fact is that effective cortical neuromodulation strategies to treat neuropathic pain target the precentral cortical region, i.e. a cortical area corresponding to the motor cortex. It is not known how these strategies might modulate brain rhythms in the central cortical region, but it can be speculated that sensorimotor rhythms (SMRs) are modified. Another potent way of modulating cortical rhythms is to use EEG-based neurofeedback (NFB). Rare studies previously aimed at relieving neuropathic pain using EEG-NFB training.
Methods/Design: The objective of this single-centre, single-blinded, randomized controlled pilot study is to assess the value of an EEG-NFB procedure to relieve chronic neuropathic pain in patients with painful peripheral neuropathy. A series of 32 patients will be randomly assigned to one of the two following EEG-NFB protocols, aimed at increasing either the low-β(SMR)/high-β ratio (n=16) or the α(μ)/θ ratio (n=16) at central (rolandic) cortical level. Various clinical outcome measures will be collected before and one week after 12 EEG-NFB sessions performed over 4 weeks. Resting-state EEG will also be recorded immediately before and after each NFB session. The primary endpoint will be the change in the impact of pain on patient\'s daily functioning, as assessed on the Interference Scale of the short form of the Brief Pain Inventory.
Discussion: The value of EEG-NFB procedures to relieve neuropathic pain has been rarely studied. This pilot study will attempt to show the value of endogenous modulation of brain rhythms in the central (rolandic) region in the frequency band corresponding to the frequency of stimulation currently used by therapeutic motor cortex stimulation. In the case of significant clinical benefit produced by the low-β(SMR)/high-β ratio increasing strategy, this work could pave the way for using EEG-NFB training within the armamentarium of neuropathic pain therapy.
Read the detailed description
1.1 - Description of the research proceedings and study design This is a single-centre, single-blinded, randomized controlled pilot study, in which 32 patients, aged between 18 and 80 years, suffering from painful peripheral neuropathy (DN4 and NRS pain scores ≥4/10), will be randomly assigned to one of the two following EEG-NFB protocols, aimed at increasing either the SMR/high-β ratio (n=16) or the μ/θ ratio (n=16) at central (rolandic) cortical level in a 1:1 allocation ratio, stratified by age and gender. The group allocation of the patients will be performed by one investigator not involved in the EEG-NFB task or clinical assessment. Patients will be recruited in the Clinical Neurophysiology department of the Henri Mondor University Hospital, Créteil, France, where the research will take place.
1.2 - Screening and inclusion visits During a routine medical visit, the study will be explained and proposed to the eligible patients and a letter of information about the protocol will be given to them. After a delay of reflection of at least a week, patients who agree to perform this research will be convened for an inclusion visit. After checking the inclusion/exclusion criteria, the informed consent form will be completed and signed by the participant and duly countersigned by the investigator.
During this visit, clinical assessment based on the fulfillment of different scales and questionnaires will be performed.
At the end of the inclusion visit, the patient will be randomized to either SMR/high-β or μ/θ training and the first EEG-NFB session will be performed.
1.3 - NFB trial The trial phase will consist of 12 EEG-NFB sessions over 4 weeks (on 3 consecutive days for 4 weeks). Each NFB session will last about 20 minutes, starting and ending with a recording of 2 minutes of resting-state EEG with eyes closed to investigate the impact of NFB on raw EEG. The NFB procedure will consist of 10 blocks of 75-second training separated by 15-second resting interval.
1.4 - Final visit and follow-up A visit will take place at the end of the trial, 7 days after the last NFB session. During this visit, subjects will be administered almost the same clinical evaluation that they received at the inclusion visit.
For the responders, defined as a reduction ≥30% of the 7-item Interference BPI score after the EEG-NFB procedure, an attempt to perform a transfer task will be proposed to the patient. From data collected during a semi-structured interview by the investigator on the strategy used by the patient to "succeed the game" during the NFB session, the mental process that the patient will have to use in the transfer task will be defined between the investigator and the patient. The purpose of the transfer task is to allow generalization of EEG-NFB benefit in real life conditions by realizing an NFB-like paradigm in which patients are invited to engage in the same cognitive strategies as for NFB but without presentation of the feedback signal.
The patient will have to perform the transfer task for 20 minutes every morning for three weeks. At the end of the third week, the investigator will make a phone call to the patient to record the 7-item Interference BPI score.
Study plan and measures:
Inclusion visit: Inclusion/exclusion criteria; Signed informed consent; DN4 questionnaire; Randomization; Baseline assessment (BFI-fr, FMI-fr, BIS-fr, CSI, Exp-LoC-Q); Primary clinical outcome measures: BPI; Other clinical outcome measures (NRS, VRS, NPSI, PCS, HAD, TMT, FSS, LSEQ) 10 EEG-NFB sessions (4 weeks): Resting-state EEG recording; EEG-NFB procedure
1 week after the last EEG-NFB session: Primary clinical outcome measures: BPI; Other clinical outcome measures (NRS, VRS, NPSI, PCS, HAD, TMT, FSS, LSEQ); Analgesic response, PGIC, Side effects After 3 weeks of transfer task (for responders to EEG-NFB): Primary clinical outcome measures: BPI
- Conditions
- Chronic Pain Syndrome, Peripheral Neuropathic Pain
- Being tested
- EEG-based neurofeedback for brain activity modulation
- Keywords
- EEG, neurofeedback, neuropathic pain, peripheral neuropathy, sensorimotor rhythm, treatment
- Medical subject headings
- Neuralgia, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-based neurofeedback for brain activity modulationOther
NFB is a type of biofeedback technique for self-modulating brain activities by means of a learning task performed with ongoing sensory (usually visual) feedback to real-time acquisition of either brain imaging or electroencephalographic (EEG) signal, which serves as a biomarker of brain activity
| Study group | Role | What they receive |
|---|---|---|
| EEG-NFB protocol aimed at increasing the low-β(SMR)/high-β ratio | Experimental | EEG neuromodulation at central (rolandic) cortical level Receives: Other: EEG-based neurofeedback for brain activity modulation |
| EEG-NFB protocol aimed at increasing the α(μ)/θ ratio | Active comparator | EEG neuromodulation at central (rolandic) cortical level Receives: Other: EEG-based neurofeedback for brain activity modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interference Scale of the short form of the Brief Pain Inventory (BPI)
The 7-item Interference Scale of the short form of the Brief Pain Inventory measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. It uses a 0 to 10 numeric rating scales for each item rating. The minimum score is 0 (no interference of pain on daily living activities, ie better outcome) and the maximum score is 70 (maximal interference of pain on daily living activities, ie worse outcome).
Measured: From enrollment to 7 days after the last NFB session
Secondary outcomes (10)
Average intensity of daily ongoing pain on a 0-10 numeric rating scale (NRS)
The 0-10 numeric rating scale (NRS) measures the average intensity of daily ongoing pain. The minimum score is 0 (no pain, ie better outcome) and the maximum score is 10 (maximal pain, ie worse outcome).
Measured: From enrollment to 7 days after the last NFB session
Average intensity of daily ongoing pain on a 0-5 verbal rating scale (VRS)
The 0-5 verbal rating scale (VRS) measures the average intensity of daily ongoing pain. The minimum score is 0 (no pain, ie better outcome) and the maximum score is 5 (unbearable pain, ie worse outcome).
Measured: From enrollment to 7 days after the last NFB session
Symptomatic profile of neuropathic pain on the Neuropathic Pain Symptom Inventory (NPSI)
The Neuropathic Pain Symptom Inventory (NPSI) measures the neuropathic pain symptoms specifically. The minimum score is 0 (no pain, ie better outcome) and the maximum score is 100 (maximal neuropathic pain symptoms, ie worse outcome).
Measured: From enrollment to 7 days after the last NFB session
Tendency to catastrophizing on the Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) measures the tendency of catastrophizing in daily life. The minimum score is 0 (no catastrophism, ie better outcome) and the maximum score is 52 (maximal tendency to catastrophizing, ie worse outcome).
Measured: From enrollment to 7 days after the last NFB session
Anxiety and depression on the Hospital Anxiety and Depression scale (HAD)
The Hospital Anxiety and Depression scale (HAD) measures the severity of anxiety and depression symptoms, with separate subscores for anxiety and depression. For each subscore, the minimum score is 0 (no anxiety or depression, ie better outcome) and the maximum score is 21 (maximal anxiety or depression, ie worse outcome).
Measured: From enrollment to 7 days after the last NFB session
Fatigue on the Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) measures the severity of fatigue. The minimum score is 0 (no fatigue, ie better outcome) and the maximum score is 63 (maximal fatigue, ie worse outcome).
Measured: From enrollment to 7 days after the last NFB session
Quality of sleep on the Leeds Sleep Evaluation Questionnaire (LSEQ).
The Leeds Sleep Evaluation Questionnaire (LSEQ) measures the quality of sleep. The minimum score is 0 (poor sleep quality, ie worse outcome) and the maximum score is 100 (maximal sleep quality, ie better outcome).
Measured: From enrollment to 7 days after the last NFB session
Dominant peak frequency (PF) of the EEG signal in each frequency band (θ, μ, low-β, and high-β)
The dominant peak frequency (PF) of the EEG signal is measured in Hz for each frequency band (θ, μ, low-β, and high-β). There is no better or worse outcome. This is a descriptive data.
Measured: At each NFB session through study completion, i.e. 4 weeks
Absolute power (AP) of the EEG signal in each frequency band (θ, μ, low-β, and high-β)
The absolute power (AP) of the EEG signal is measured in µV² for each frequency band (θ, μ, low-β, and high-β). There is no better or worse outcome. This is a descriptive data.
Measured: At each NFB session through study completion, i.e. 4 weeks
Relative power (RP) of the EEG signal in each frequency band (θ, μ, low-β, and high-β)
The relative power (RP) of the EEG signal is measured in % for each frequency band (θ, μ, low-β, and high-β). There is no better or worse outcome. This is a descriptive data.
Measured: At each NFB session through study completion, i.e. 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start4 Jan 2021
- Primary completion16 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Vialatte, Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234917
- Sponsor's protocol ID
- 2020-A00514-35
- Acronym
- SMR-Pain
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relieving Peripheral Neuropathic Pain by Increasing the Power-ratio of Low-β Over High-β Activities in the Central Cortical Region With EEG-based Neurofeedback: Study Protocol for a Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06234917
- Acronym / sponsor ID
- SMR-Pain / 2020-A00514-35
- Conditions
- Chronic Pain Syndrome, Peripheral Neuropathic Pain
- Keywords
- EEG, neurofeedback, neuropathic pain, peripheral neuropathy, sensorimotor rhythm, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy)University, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 31 Jan 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.
Background: Chronic neuropathic pain associated with peripheral neuropathies cannot be attributed solely to lesions of peripheral sensory axons and likely involves alteration in the processing of nociceptive information in the central nervous system in most patients. Few data are available regarding EEG correlates of chronic neuropathic pain. The fact is that effective cortical neuromodulation strategies to treat neuropathic pain target the precentral cortical region, i.e. a cortical area corresponding to the motor cortex. It is not known how these strategies might modulate brain rhythms in the central cortical region, but it can be speculated that sensorimotor rhythms (SMRs) are modified. Another potent way of modulating cortical rhythms is to use EEG-based neurofeedback (NFB). Rare studies previously aimed at relieving neuropathic pain using EEG-NFB training.
Methods/Design: The objective of this single-centre, single-blinded, randomized controlled pilot study is to assess the value of an EEG-NFB procedure to relieve chronic neuropathic pain in patients with painful peripheral neuropathy. A series of 32 patients will be randomly assigned to one of the two following EEG-NFB protocols, aimed at increasing either the low-β(SMR)/high-β ratio (n=16) or the α(μ)/θ ratio (n=16) at central (rolandic) cortical level. Various clinical outcome measures will be collected before and one week after 12 EEG-NFB sessions performed over 4 weeks. Resting-state EEG will also be recorded immediately before and after each NFB session. The primary endpoint will be the change in the impact of pain on patient\'s daily functioning, as assessed on the Interference Scale of the short form of the Brief Pain Inventory.
Discussion: The value of EEG-NFB procedures to relieve neuropathic pain has been rarely studied. This pilot study will attempt to show the value of endogenous modulation of brain rhythms in the central (rolandic) region in the frequency band corresponding to the frequency of stimulation currently used by therapeutic motor cortex stimulation. In the case of significant clinical benefit produced by the low-β(SMR)/high-β ratio increasing strategy, this work could pave the way for using EEG-NFB training within the armamentarium of neuropathic pain therapy.
Detailed description
1.1 - Description of the research proceedings and study design This is a single-centre, single-blinded, randomized controlled pilot study, in which 32 patients, aged between 18 and 80 years, suffering from painful peripheral neuropathy (DN4 and NRS pain scores ≥4/10), will be randomly assigned to one of the two following EEG-NFB protocols, aimed at increasing either the SMR/high-β ratio (n=16) or the μ/θ ratio (n=16) at central (rolandic) cortical level in a 1:1 allocation ratio, stratified by age and gender. The group allocation of the patients will be performed by one investigator not involved in the EEG-NFB task or clinical assessment. Patients will be recruited in the Clinical Neurophysiology department of the Henri Mondor University Hospital, Créteil, France, where the research will take place.
1.2 - Screening and inclusion visits During a routine medical visit, the study will be explained and proposed to the eligible patients and a letter of information about the protocol will be given to them. After a delay of reflection of at least a week, patients who agree to perform this research will be convened for an inclusion visit. After checking the inclusion/exclusion criteria, the informed consent form will be completed and signed by the participant and duly countersigned by the investigator.
During this visit, clinical assessment based on the fulfillment of different scales and questionnaires will be performed.
At the end of the inclusion visit, the patient will be randomized to either SMR/high-β or μ/θ training and the first EEG-NFB session will be performed.
1.3 - NFB trial The trial phase will consist of 12 EEG-NFB sessions over 4 weeks (on 3 consecutive days for 4 weeks). Each NFB session will last about 20 minutes, starting and ending with a recording of 2 minutes of resting-state EEG with eyes closed to investigate the impact of NFB on raw EEG. The NFB procedure will consist of 10 blocks of 75-second training separated by 15-second resting interval.
1.4 - Final visit and follow-up A visit will take place at the end of the trial, 7 days after the last NFB session. During this visit, subjects will be administered almost the same clinical evaluation that they received at the inclusion visit.
For the responders, defined as a reduction ≥30% of the 7-item Interference BPI score after the EEG-NFB procedure, an attempt to perform a transfer task will be proposed to the patient. From data collected during a semi-structured interview by the investigator on the strategy used by the patient to "succeed the game" during the NFB session, the mental process that the patient will have to use in the transfer task will be defined between the investigator and the patient. The purpose of the transfer task is to allow generalization of EEG-NFB benefit in real life conditions by realizing an NFB-like paradigm in which patients are invited to engage in the same cognitive strategies as for NFB but without presentation of the feedback signal.
The patient will have to perform the transfer task for 20 minutes every morning for three weeks. At the end of the third week, the investigator will make a phone call to the patient to record the 7-item Interference BPI score.
Study plan and measures:
Inclusion visit: Inclusion/exclusion criteria; Signed informed consent; DN4 questionnaire; Randomization; Baseline assessment (BFI-fr, FMI-fr, BIS-fr, CSI, Exp-LoC-Q); Primary clinical outcome measures: BPI; Other clinical outcome measures (NRS, VRS, NPSI, PCS, HAD, TMT, FSS, LSEQ) 10 EEG-NFB sessions (4 weeks): Resting-state EEG recording; EEG-NFB procedure
1 week after the last EEG-NFB session: Primary clinical outcome measures: BPI; Other clinical outcome measures (NRS, VRS, NPSI, PCS, HAD, TMT, FSS, LSEQ); Analgesic response, PGIC, Side effects After 3 weeks of transfer task (for responders to EEG-NFB): Primary clinical outcome measures: BPI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG-NFB protocol aimed at increasing the low-β(SMR)/high-β ratio | Experimental | Other: EEG-based neurofeedback for brain activity modulationEEG neuromodulation at central (rolandic) cortical level |
| EEG-NFB protocol aimed at increasing the α(μ)/θ ratio | Active comparator | Other: EEG-based neurofeedback for brain activity modulationEEG neuromodulation at central (rolandic) cortical level |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Definite peripheral neuropathy on both clinical and neurophysiological grounds, present for at least 6 months.
- Neuropathic pain clearly related to the neuropathy, as defined by a score ≥ 4/10 on the DN4 questionnaire.
- Score ≥ 4/10 on a 0-10 numerical rating scale (NRS) concerning the average intensity of daily ongoing pain.
- Age between 18 and 80 years.
- Affiliation with the social security system.
Key exclusion criteria (4 listed)
- Neurological disorder other than peripheral neuropathy (neurodegenerative disorders, migraine, epilepsy, stroke, tumor).
- Psychiatric illness.
- Major visual disturbance.
- -
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 |
|---|---|---|
| EEG-based neurofeedback for brain activity modulationNFB is a type of biofeedback technique for self-modulating brain activities by means of a learning task performed with ongoing sensory (usually visual) feedback to real-time acquisition of either brain imaging or electroencephalographic (EEG) signal, which serves as a biomarker of brain activity | Other | EEG-NFB protocol aimed at increasing the low-β(SMR)/high-β ratio, EEG-NFB protocol aimed at increasing the α(μ)/θ ratio |
Primary outcome
Interference Scale of the short form of the Brief Pain Inventory (BPI)
Time frame: From enrollment to 7 days after the last NFB session
The 7-item Interference Scale of the short form of the Brief Pain Inventory measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. It uses a 0 to 10 numeric rating scales for each item rating. The minimum score is 0 (no interference of pain on daily living activities, ie better outcome) and the maximum score is 70 (maximal interference of pain on daily living activities, ie worse outcome).
10 secondary outcomes
Average intensity of daily ongoing pain on a 0-10 numeric rating scale (NRS)
Time frame: From enrollment to 7 days after the last NFB session
Average intensity of daily ongoing pain on a 0-5 verbal rating scale (VRS)
Time frame: From enrollment to 7 days after the last NFB session
Symptomatic profile of neuropathic pain on the Neuropathic Pain Symptom Inventory (NPSI)
Time frame: From enrollment to 7 days after the last NFB session
Tendency to catastrophizing on the Pain Catastrophizing Scale (PCS)
Time frame: From enrollment to 7 days after the last NFB session
Anxiety and depression on the Hospital Anxiety and Depression scale (HAD)
Time frame: From enrollment to 7 days after the last NFB session
Fatigue on the Fatigue Severity Scale (FSS)
Time frame: From enrollment to 7 days after the last NFB session
Quality of sleep on the Leeds Sleep Evaluation Questionnaire (LSEQ).
Time frame: From enrollment to 7 days after the last NFB session
Dominant peak frequency (PF) of the EEG signal in each frequency band (θ, μ, low-β, and high-β)
Time frame: At each NFB session through study completion, i.e. 4 weeks
Absolute power (AP) of the EEG signal in each frequency band (θ, μ, low-β, and high-β)
Time frame: At each NFB session through study completion, i.e. 4 weeks
Relative power (RP) of the EEG signal in each frequency band (θ, μ, low-β, and high-β)
Time frame: At each NFB session through study completion, i.e. 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG-based neurofeedback for brain activity modulation in people with Chronic Pain Syndrome and Peripheral Neuropathic Pain, run by Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy) at 1 site in France.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jan 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interference Scale of the short form of the Brief Pain Inventory (BPI) (time frame: From enrollment to 7 days after the last NFB session). 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 31 Jan 2024.