Noninvasive Brain Stimulation Training (TrainingNIBS)
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|ClinicalTrials.gov Identifier: NCT03228472|
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : November 27, 2017
Non-invasive cerebral stimulation techniques have shown potential in the treatment of neurological disorders such as chronic pain, Parkinson's disease, neglect, aphasia, memory, engine deficit and epilepsy In general, non-invasive cerebral stimulation techniques have been shown to be able to induce changes in cortical plasticity that may last even beyond the end of the stimulation period. Considering this potential, there is growing interest in the application of these therapeutic techniques.
Hypotheses Based on these assumptions, the underlying hypothesis behind this project is that the therapeutic use of cranial - electrical or magnetic stimulation - can aid the recovery of various brain injury symptoms.
Specific objectives This study aims to provide preliminary data about the benefits of using cortical stimulation to recover various brain injury symptoms. This will be made possible thanks to the specific skills of a multidisciplinary team of neurologists and physiatrists, healthcare professionals such as physiotherapists, occupational therapists, psychologists, speech therapists and the support of a biomedical engineer. These professional figures are already available at the UCK Neurosurgery of the IRCCS Neuromed directed by the proposer and actively collaborate to optimize the therapeutic exercise of patients with neurological damage.
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries||Device: non invasive brain stimulation Device: sham stimulation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will undergo a cerebral pacing program listed below and differentiated according to the type of symptom presented. All conventional therapies taken by patients will be recorded by the operators. Patients will be divided into Stimulation and Sham (control) groups and will be evaluated at zero time before starting treatment (T-0W) after 6 weeks to evaluate the effects at the end of treatment (T-6W) and at 12 weeks (T-12W) to evaluate the maintenance of long-term effects. Randomization will be balanced in accordance with age, sex and schooling.|
|Masking:||None (Open Label)|
|Official Title:||Noninvasive Brain Stimulation Training to Help Recover Brain-related Symptoms|
|Actual Study Start Date :||November 22, 2017|
|Estimated Primary Completion Date :||July 12, 2018|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: real stimulation
Cranial - electrical or magnetic stimulation. Stimulation will be different according to clinical conditions, as specified elsewhere.
Device: non invasive brain stimulation
TDCS stimulation will be administered for 5 consecutive days at 2 mA for 20 minutes.
TMS stimulation parameters will be: 10 Hz frequency; 100% RMT intensity; Train duration 10 sec (100 stimuli); Inter-train interval 1 minute; n. Total of the terrors 12; Duration of a session about 13 minutes.
Placebo Comparator: sham stimulation
Patients will be treated as in the "Real stimulation" arm, but no electrical or magnetic stimulation will be induced.
Device: sham stimulation
- quality of life [ Time Frame: up to 3 years ]Barthel's Activities of Daily Living (ADL) (O'Sullivan et al 2007)
- FIM [ Time Frame: up to 3 years ]Functional Independence Measurement (FIM) (Chumney et al., 2010)
- stroke [ Time Frame: up to 3 years ]NIH Stroke Scale / Score (NIHSS)
- disability [ Time Frame: up to 3 years ]Expanded Disability Status Scale (EDSS) (Kurtzke, 1983)
- parkinson [ Time Frame: up to 3 years ]Unified Parkinson's Disease Rating Scale (Rammer et al. )
- depression [ Time Frame: up to 3 years ]Beck Depression Inventory (BDI) (Beck, 1972)
- neuronal plasticity [ Time Frame: up to 3 years ]Transcranial Magnetic Stimulation (TMS) will be used to evaluate the change of neuronal plasticity in a subgroup of patients who will not present contraindications to the method. The TMS uses short-lived magnetic fields and high intensity applied at the scalp level to activate the neurons of a small region of the cerebral cortex through an electromagnetic induction. When these impulses are applied repeatedly, it is possible to induce plastic modification of cortical excitability. If these changes are induced at the level of the motor cortex, they can be measured by recording a motor evoked potential (MEP) at the muscle level represented at the stimulated region level. Any increase or decrease in AMP amplitude, which persists after the end of TMS repetitive stimulation, indicates that there have been changes in the cortical, LTP or depression (LTD).
- locomotion and posture [ Time Frame: up to 3 years ]Stabilometric Platform
- locomotion and posture [ Time Frame: up to 3 years ]Gait Analysis
- deglutition [ Time Frame: up to 3 years ]Electrophysiological and Fiberendoscopic Deglutition Study
- Cognition [ Time Frame: up to 3 years ]ad-hoc task
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228472
|Pozzilli, Isernia, Italy, 86077|
|Contact: Stefania Passarelli +39 0865.915217 firstname.lastname@example.org|