Brain Injuries Clinical Trial
— TrainingNIBSOfficial title:
Noninvasive Brain Stimulation Training to Help Recover Brain-related Symptoms
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | The sample estimate was made by analogy after a literature analysis. Considering the risk of abandonment quite high, our intention is to recruit at least 100 subjects in a population of patients with cerebral injury who are involved in the neurological department of I.R.R.C.S. Neuromed by Pozzilli, featuring the symptoms described below in the inclusion criteria Inclusion criteria: - Males or females aged between 18 and 80; - Presence of: Disinfection, Multiple Sclerosis, Depression, Sensory Disorder or Neuropathic Pain; - Female subjects can not be pregnant, can not breastfeed, have been born at least three months before the beginning of the study, undertake not to schedule a pregnancy for the duration of the study; - Patients should be able to follow protocol guidelines throughout the study; - Patients should be able to understand the aims and risks of the study; - Signature of informed consent, approved by our Ethics Committee. Exclusion criteria: - Tumors or systemic infections; - Patients with impaired hepatic function (ALT> 3 x Upper Limit Normal (ULN), Alkaline Phosphatase> 2 x ULN, bilirubin tot> 2 x ULN if associated with any increase in ALT or alkaline phosphatase); Severe or moderate renal failure; - Patients with TMS or tDCS (pacemaker, intracerebral metal clip, epilepsy ...) - Patients with other pathologies which, according to the scientific officer's opinion, prevent recruitment; - Patients unable to even partially understand and want. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Neuromed | Pozzilli | Isernia |
Lead Sponsor | Collaborator |
---|---|
Neuromed IRCCS |
Italy,
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Barthel's Activities of Daily Living (ADL) (O'Sullivan et al 2007) | Abilities of daily living | up to 3 years | |
Primary | FIM | Functional Independence Measurement (FIM) (Chumney et al., 2010) | up to 3 years | |
Primary | stroke | NIH Stroke Scale / Score (NIHSS) | up to 3 years | |
Primary | disability | Expanded Disability Status Scale (EDSS) (Kurtzke, 1983) | up to 3 years | |
Primary | parkinson | Unified Parkinson's Disease Rating Scale (Rammer et al. ) | up to 3 years | |
Primary | depression | Beck Depression Inventory (BDI) (Beck, 1972) | up to 3 years | |
Secondary | neuronal plasticity | 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). | up to 3 years | |
Secondary | posture | Stabilometric Platform | up to 3 years | |
Secondary | locomotion | Gait Analysis | up to 3 years | |
Secondary | deglutition | Electrophysiological and Fiberendoscopic Deglutition Study | up to 3 years | |
Secondary | Cognition | ad-hoc task | up to 3 years |
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