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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Interference Scale of the short form of the Brief Pain Inventory (BPI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Neurological disorder other than peripheral neuropathy (neurodegenerative disorders, migraine, epilepsy, stroke, tumor).
- •Psychiatric illness.
- •Major visual disturbance.
- •Exclusion Criteria:
结局指标
主要结局
Interference Scale of the short form of the Brief Pain Inventory (BPI)
时间窗: 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).
次要结局
- Average intensity of daily ongoing pain on a 0-5 verbal rating scale (VRS)(From enrollment to 7 days after the last NFB session)
- Quality of sleep on the Leeds Sleep Evaluation Questionnaire (LSEQ).(From enrollment to 7 days after the last NFB session)
- Average intensity of daily ongoing pain on a 0-10 numeric rating scale (NRS)(From enrollment to 7 days after the last NFB session)
- Symptomatic profile of neuropathic pain on the Neuropathic Pain Symptom Inventory (NPSI)(From enrollment to 7 days after the last NFB session)
- Tendency to catastrophizing on the Pain Catastrophizing Scale (PCS)(From enrollment to 7 days after the last NFB session)
- Anxiety and depression on the Hospital Anxiety and Depression scale (HAD)(From enrollment to 7 days after the last NFB session)
- Fatigue on the Fatigue Severity Scale (FSS)(From enrollment to 7 days after the last NFB session)
- Absolute power (AP) of the EEG signal in each frequency band (θ, μ, low-β, and high-β)(At each NFB session through study completion, i.e. 4 weeks)
- Dominant peak frequency (PF) of the EEG signal in each frequency band (θ, μ, low-β, and high-β)(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)(At each NFB session through study completion, i.e. 4 weeks)
研究者
François Vialatte
Director of PiPsy Institute
Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy)