Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Development of neuropathic pain
研究概览
简要总结
This is a prospective clinical study to evaluate the efficacy of tDCS stimulation, coupled with conventional rehabilitation, on the development of post-stroke neuropathic pain.
The study involves a double-blind, randomized, sham-controlled experimental protocol involving 2 parallel groups with patients allocated according to a Fleming design (40 patients in the active group, 20 patients in the control group).
The study is aimed at sub-acute post-stroke patients. After recruitment, they will receive 10 sessions of tDCS stimulation (2mA, 20 minutes with a current on/off ramp of 0.1 mA/s). For the control group, stimulation will stop after the current ramp.
详细描述
Selection: during hospitalization in the neurology department of Clermont-Ferrand University Hospital, the principal investigator will propose that eligible patients take part in the ENADA study. If the patient agrees, an inclusion visit (E1) will be scheduled by the inclusion center. All these patients will have had an MRI recording as part of routine post-stroke practice.
Inclusion (E1 visit): A new background check and inclusion/non-inclusion criteria will be carried out. Once the patient has signed the study consent form, he or she will complete the self-questionnaires (VAS pain intensity, VAS pain affectivity, DN4, NPSI, BPI, HAD, diagram showing hypoesthetic areas, EQ-5D). The evaluation will also include FMA-UE test, the modified Ashworth scale and sensory thresholds.
Randomization: Patients will be randomized to the active or placebo group.
Protocol: 10 stimulation sessions, spread over a maximum of 21 consecutive working days.
Active and sham tDCS sessions are identical, double-blind. Stimulation by tDCS takes place during a physiotherapy, occupational therapy or speech therapy session. After installation, stimulation lasts 20 minutes. Stimulation is delivered at an intensity of 2 mA, with a ramp for the onset and disappearance of the current. Sham stimulation stops after the onset ramp, ensuring blindness for the patient, who may feel a slight tingling sensation during this phase. Patients will complete a pain intensity VAS and an affective pain VAS before and after each tDCS stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Ischemic or hemorrhagic stroke confirmed by MRI or scanner
- •Lesion(s) in somato-sensory areas (i.e. mainly in: the pons, thalamus, internal capsule, basal ganglia and operculo-insular regions)
- •Sensory and/or motor deficit requiring rehabilitation
- •Subacute stage (7 to 45 days post-stroke)
- •No neurological deficit or chronic neuropathic pain prior to stroke
- •No neuropathic pain at inclusion
- •Patient can be followed throughout the study.
- •Information letter read and understood
- •Able to give informed consent to participate in research
- •Affiliation with a social security scheme
排除标准
- •Contraindication to tDCS (epilepsy/history of epilepsy, intracranial ferromagnetic material or implanted stimulator, acute eczema or irritated skin over the stimulation area)
- •Contraindication to MRI (use of a pacemaker or insulin pump, wearing of a metal prosthesis, intracerebral clip or piercing, claustrophobia)
- •Cognitive or language difficulties preventing comprehension of instructions and/or correct clinical assessment
- •Patients participating in another research protocol involving a drug in the 30 days prior to inclusion
- •Drug or psychoactive substance abuse
- •Pregnant or breast-feeding women
- •Patients under guardianship or curatorship, deprived of liberty, safeguard of justice
- •Major depression
- •Patients with Parkinson's disease
- •The presence of pre-existing lesions >1.5 cm (maximum diameter) in a cerebral area belonging to the anatomically defined sensorimotor system
- •Alcohol abuse
- •Severe psychiatric disorders (e.g., schizophrenia)
- •Any tumor disease with a life expectancy of <1 year
- •Increased intracranial pressure
- •Patients with a medical device containing electronics or conductive materials
- •Patients on continuous oxygen (system not adapted)
研究组 & 干预措施
Active group
Patients will receive 10 sessions of active tDCS stimulation (2mA, 20 minutes, 0.1mA/s ramp-up and ramp-down), in addition to conventional rehabilitation.
干预措施: Active tDCS (Device)
Control group
Patients will receive 10 sessions of sham tDCS stimulation (2mA, 20 minutes, 0.1mA/s ramp-up, stimulation stopped after the current ramp), in addition to conventional rehabilitation.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Development of neuropathic pain
时间窗: At 6 months post-stroke
The primary endpoint is the development (yes/no) of probable or definite neuropathic pain according to IASP criteria, after clinical and instrumental assessment, at 6 months post-stroke. The presence of definite neuropathic pain will be recorded in the presence of negative sensory signs, i.e. partial or complete loss of one or more sensory modalities (e.g. light touch, cold temperature, etc.) concordant with the lesion of the somatosensory nervous system (in this case stroke, the presence of which will have been confirmed by MRI).
次要结局
- Development of non-neuropathic pain(At 6 months post-stroke)
- Affective pain experience(Before the protocol, within 15 minutes before and after each tDCS session, after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Presence of neuropathic pain(Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Pain intensity(Before the protocol, within 15 minutes before and after each tDCS session, after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Evaluation of neuropathic pain(Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Pain assessment(Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Motor function(Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Spasticity(Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Anxiety and depression(Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Perceptual and pain hot and cold thresholds(Before the protocol and at six months post-stroke)
- Brain activity(Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Quality of life EQ-5D(Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Patient's impression of change(After the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)
- Bang Blinding Index(After the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke)