Noninvasive Brain Stimulation Training

NCT03228472 | Unknown

• 1 other identifier: IRCCS_Neuromed
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (6)

• Barthel's Activities of Daily Living (ADL) (O'Sullivan et al 2007)

  Abilities of daily living

  up to 3 years

• FIM

  Functional Independence Measurement (FIM) (Chumney et al., 2010)

  up to 3 years

• stroke

  NIH Stroke Scale / Score (NIHSS)

  up to 3 years

• disability

  Expanded Disability Status Scale (EDSS) (Kurtzke, 1983)

  up to 3 years

• parkinson

  Unified Parkinson's Disease Rating Scale (Rammer et al. )

  up to 3 years

• depression

  Beck Depression Inventory (BDI) (Beck, 1972)

  up to 3 years

Secondary Outcomes (5)

• neuronal plasticity

  up to 3 years

• posture

  up to 3 years

• locomotion

  up to 3 years

• deglutition

  up to 3 years

• Cognition

  up to 3 years

Study Arms (2)

real stimulation

EXPERIMENTAL

Cranial - electrical or magnetic stimulation. Stimulation will be different according to clinical conditions, as specified elsewhere.

Device: non invasive brain stimulation

sham stimulation

PLACEBO COMPARATOR

Patients will be treated as in the "Real stimulation" arm, but no electrical or magnetic stimulation will be induced.

Device: sham stimulation

Interventions

non invasive brain stimulation DEVICE

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.

real stimulation

sham stimulation DEVICE

Placebo treatment

sham stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS Neuromed

Pozzilli, Isernia, 86077, Italy

RECRUITING

Related Publications (31)

• Antal A, Brepohl N, Poreisz C, Boros K, Csifcsak G, Paulus W. Transcranial direct current stimulation over somatosensory cortex decreases experimentally induced acute pain perception. Clin J Pain. 2008 Jan;24(1):56-63. doi: 10.1097/AJP.0b013e318157233b.

  PMID: 18180638 BACKGROUND

• Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. doi: 10.1016/s0140-6736(85)92413-4. No abstract available.

  PMID: 2860322 BACKGROUND

• Baxter LR Jr. Neuroimaging studies of obsessive compulsive disorder. Psychiatr Clin North Am. 1992 Dec;15(4):871-84.

  PMID: 1461802 BACKGROUND

• Ben-Shachar D, Belmaker RH, Grisaru N, Klein E. Transcranial magnetic stimulation induces alterations in brain monoamines. J Neural Transm (Vienna). 1997;104(2-3):191-7. doi: 10.1007/BF01273180.

  PMID: 9203081 BACKGROUND

• Boggio PS, Zaghi S, Lopes M, Fregni F. Modulatory effects of anodal transcranial direct current stimulation on perception and pain thresholds in healthy volunteers. Eur J Neurol. 2008 Oct;15(10):1124-30. doi: 10.1111/j.1468-1331.2008.02270.x. Epub 2008 Aug 20.

  PMID: 18717717 BACKGROUND

• Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398.

  PMID: 9153480 BACKGROUND

• Dieckhofer A, Waberski TD, Nitsche M, Paulus W, Buchner H, Gobbele R. Transcranial direct current stimulation applied over the somatosensory cortex - differential effect on low and high frequency SEPs. Clin Neurophysiol. 2006 Oct;117(10):2221-7. doi: 10.1016/j.clinph.2006.07.136. Epub 2006 Aug 23.

  PMID: 16931142 BACKGROUND

• Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.

  PMID: 16564618 BACKGROUND

• Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195.

  PMID: 17133529 BACKGROUND

• George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008.

  PMID: 8547583 BACKGROUND

• Greenberg BD, George MS, Martin JD, Benjamin J, Schlaepfer TE, Altemus M, Wassermann EM, Post RM, Murphy DL. Effect of prefrontal repetitive transcranial magnetic stimulation in obsessive-compulsive disorder: a preliminary study. Am J Psychiatry. 1997 Jun;154(6):867-9. doi: 10.1176/ajp.154.6.867.

  PMID: 9167520 BACKGROUND

• Hamdy S, Rothwell JC. Gut feelings about recovery after stroke: the organization and reorganization of human swallowing motor cortex. Trends Neurosci. 1998 Jul;21(7):278-82. doi: 10.1016/s0166-2236(97)01212-5.

  PMID: 9683316 BACKGROUND

• Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. doi: 10.1093/brain/awh369. Epub 2005 Jan 5.

  PMID: 15634731 BACKGROUND

• Hummel F, Cohen LG. Improvement of motor function with noninvasive cortical stimulation in a patient with chronic stroke. Neurorehabil Neural Repair. 2005 Mar;19(1):14-9. doi: 10.1177/1545968304272698.

  PMID: 15673839 BACKGROUND

• Matsunaga K, Nitsche MA, Tsuji S, Rothwell JC. Effect of transcranial DC sensorimotor cortex stimulation on somatosensory evoked potentials in humans. Clin Neurophysiol. 2004 Feb;115(2):456-60. doi: 10.1016/s1388-2457(03)00362-6.

  PMID: 14744588 BACKGROUND

• Mori F, Codeca C, Kusayanagi H, Monteleone F, Buttari F, Fiore S, Bernardi G, Koch G, Centonze D. Effects of anodal transcranial direct current stimulation on chronic neuropathic pain in patients with multiple sclerosis. J Pain. 2010 May;11(5):436-42. doi: 10.1016/j.jpain.2009.08.011. Epub 2009 Dec 16.

  PMID: 20018567 BACKGROUND

• Mori F, Nicoletti CG, Kusayanagi H, Foti C, Restivo DA, Marciani MG, Centonze D. Transcranial direct current stimulation ameliorates tactile sensory deficit in multiple sclerosis. Brain Stimul. 2013 Jul;6(4):654-9. doi: 10.1016/j.brs.2012.10.003. Epub 2012 Oct 27.

  PMID: 23122918 BACKGROUND

• Pascual-Leone A, Valls-Sole J, Wassermann EM, Hallett M. Responses to rapid-rate transcranial magnetic stimulation of the human motor cortex. Brain. 1994 Aug;117 ( Pt 4):847-58. doi: 10.1093/brain/117.4.847.

  PMID: 7922470 BACKGROUND

• Pridmore S. Substitution of rapid transcranial magnetic stimulation treatments for electroconvulsive therapy treatments in a course of electroconvulsive therapy. Depress Anxiety. 2000;12(3):118-23. doi: 10.1002/1520-6394(2000)12:33.0.CO;2-G.

  PMID: 11126185 BACKGROUND

• Que M, Schiene K, Witte OW, Zilles K. Widespread up-regulation of N-methyl-D-aspartate receptors after focal photothrombotic lesion in rat brain. Neurosci Lett. 1999 Oct 1;273(2):77-80. doi: 10.1016/s0304-3940(99)00598-4.

  PMID: 10505620 BACKGROUND

• Ragert P, Dinse HR, Pleger B, Wilimzig C, Frombach E, Schwenkreis P, Tegenthoff M. Combination of 5 Hz repetitive transcranial magnetic stimulation (rTMS) and tactile coactivation boosts tactile discrimination in humans. Neurosci Lett. 2003 Sep 11;348(2):105-8. doi: 10.1016/s0304-3940(03)00745-6.

  PMID: 12902029 BACKGROUND

• Ragert P, Franzkowiak S, Schwenkreis P, Tegenthoff M, Dinse HR. Improvement of tactile perception and enhancement of cortical excitability through intermittent theta burst rTMS over human primary somatosensory cortex. Exp Brain Res. 2008 Jan;184(1):1-11. doi: 10.1007/s00221-007-1073-2. Epub 2007 Aug 7.

  PMID: 17680239 BACKGROUND

• Ragert P, Vandermeeren Y, Camus M, Cohen LG. Improvement of spatial tactile acuity by transcranial direct current stimulation. Clin Neurophysiol. 2008 Apr;119(4):805-11. doi: 10.1016/j.clinph.2007.12.001. Epub 2008 Jan 18.

  PMID: 18203660 BACKGROUND

• Ridding MC, Sheean G, Rothwell JC, Inzelberg R, Kujirai T. Changes in the balance between motor cortical excitation and inhibition in focal, task specific dystonia. J Neurol Neurosurg Psychiatry. 1995 Nov;59(5):493-8. doi: 10.1136/jnnp.59.5.493.

  PMID: 8530933 BACKGROUND

• Rogalewski A, Breitenstein C, Nitsche MA, Paulus W, Knecht S. Transcranial direct current stimulation disrupts tactile perception. Eur J Neurosci. 2004 Jul;20(1):313-6. doi: 10.1111/j.0953-816X.2004.03450.x.

  PMID: 15245504 BACKGROUND

• Rossini PM, Calautti C, Pauri F, Baron JC. Post-stroke plastic reorganisation in the adult brain. Lancet Neurol. 2003 Aug;2(8):493-502. doi: 10.1016/s1474-4422(03)00485-x.

  PMID: 12878437 BACKGROUND

• Siebner HR, Tormos JM, Ceballos-Baumann AO, Auer C, Catala MD, Conrad B, Pascual-Leone A. Low-frequency repetitive transcranial magnetic stimulation of the motor cortex in writer's cramp. Neurology. 1999 Feb;52(3):529-37. doi: 10.1212/wnl.52.3.529.

  PMID: 10025782 BACKGROUND

• Siebner HR, Rothwell J. Transcranial magnetic stimulation: new insights into representational cortical plasticity. Exp Brain Res. 2003 Jan;148(1):1-16. doi: 10.1007/s00221-002-1234-2. Epub 2002 Nov 5.

  PMID: 12478392 BACKGROUND

• Speer AM, Kimbrell TA, Wassermann EM, D Repella J, Willis MW, Herscovitch P, Post RM. Opposite effects of high and low frequency rTMS on regional brain activity in depressed patients. Biol Psychiatry. 2000 Dec 15;48(12):1133-41. doi: 10.1016/s0006-3223(00)01065-9.

  PMID: 11137053 BACKGROUND

• Tegenthoff M, Ragert P, Pleger B, Schwenkreis P, Forster AF, Nicolas V, Dinse HR. Improvement of tactile discrimination performance and enlargement of cortical somatosensory maps after 5 Hz rTMS. PLoS Biol. 2005 Nov;3(11):e362. doi: 10.1371/journal.pbio.0030362. Epub 2005 Oct 18.

  PMID: 16218766 BACKGROUND

• Wassermann EM, Grafman J, Berry C, Hollnagel C, Wild K, Clark K, Hallett M. Use and safety of a new repetitive transcranial magnetic stimulator. Electroencephalogr Clin Neurophysiol. 1996 Oct;101(5):412-7.

  PMID: 8913194 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Diego Centonze, MD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Centonze, MD

CONTACT

+39 3934444159; centonze@uniroma2.it

Mario Stampanoni Bassi, MD

CONTACT

+39 3460181370; mario_sb@hotmail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 25, 2017
• Study Start: November 22, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)