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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
Sponsor:
Information provided by (Responsible Party):
Neuromed IRCCS

Brief Summary:

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
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
Placebo treatment



Primary Outcome Measures :
  1. quality of life [ Time Frame: up to 3 years ]
    Barthel's Activities of Daily Living (ADL) (O'Sullivan et al 2007)

  2. FIM [ Time Frame: up to 3 years ]
    Functional Independence Measurement (FIM) (Chumney et al., 2010)

  3. stroke [ Time Frame: up to 3 years ]
    NIH Stroke Scale / Score (NIHSS)

  4. disability [ Time Frame: up to 3 years ]
    Expanded Disability Status Scale (EDSS) (Kurtzke, 1983)

  5. parkinson [ Time Frame: up to 3 years ]
    Unified Parkinson's Disease Rating Scale (Rammer et al. )

  6. depression [ Time Frame: up to 3 years ]
    Beck Depression Inventory (BDI) (Beck, 1972)


Secondary Outcome Measures :
  1. 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).

  2. locomotion and posture [ Time Frame: up to 3 years ]
    Stabilometric Platform

  3. locomotion and posture [ Time Frame: up to 3 years ]
    Gait Analysis

  4. deglutition [ Time Frame: up to 3 years ]
    Electrophysiological and Fiberendoscopic Deglutition Study

  5. Cognition [ Time Frame: up to 3 years ]
    ad-hoc task



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
Italy
IRCCS Neuromed Recruiting
Pozzilli, Isernia, Italy, 86077
Contact: Stefania Passarelli    +39 0865.915217    direzionescientifica@neuromed.it   
Sponsors and Collaborators
Neuromed IRCCS

Publications:

Responsible Party: Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT03228472     History of Changes
Other Study ID Numbers: IRCCS_Neuromed
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries