Noninvasive brain stimulation for recovery from brain injuries
Noninvasive Brain Stimulation Training to Help Recover Brain-related Symptoms
This study is testing if non-invasive brain stimulation techniques can help people with brain injuries recover from symptoms like depression and sensory issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Neuromed IRCCS Academic / other |
| Locations | 1 site (Pozzilli, Isernia) |
| Trial ID | NCT03228472 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of non-invasive brain stimulation techniques, specifically transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), on patients with various brain injuries. The aim is to assess the potential benefits of these techniques in enhancing recovery from symptoms associated with brain injuries, such as depression and sensory disorders. Participants will receive either active stimulation or a sham treatment to evaluate the efficacy of the interventions. A multidisciplinary team of neurologists and physiatrists will oversee the study to ensure comprehensive care and accurate data collection.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 80 with specific neurological conditions such as multiple sclerosis, depression, or sensory disorders.
Not a fit: Patients with tumors or systemic infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with brain injuries.
How similar studies have performed: Previous studies have shown promising results with non-invasive brain stimulation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pozzilli, Isernia
- IRCCS Neuromed — Pozzilli, Isernia, Italy (Recruiting)
Study contacts
- Principal investigator: Diego Centonze, MD — IRCCS Neuromed
- Study coordinator: Diego Centonze, MD
- Email: centonze@uniroma2.it
- Phone: +39 3934444159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.