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Cerebellar rTMS to Improve Gait Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456362
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Giacomo Koch, I.R.C.C.S. Fondazione Santa Lucia

Brief Summary:
The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in stroke patients, especially for gait an balance functions. Repetitive transcranial magnetic stimulation of the cerebellum can be used to enhance these adaptive processes in stroke recovery. In this randomized, double blind, sham-controlled trial we aim to investigate the efficacy and safety of cerebellar intermittent theta burst stimulation coupled with intensive physical therapy in promoting gait recovery in hemiparetic patients due to recent stroke in the territory of the contralateral middle cerebral artery

Condition or disease Intervention/treatment Phase
Stroke Gait, Hemiplegic Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Promoting Motor Recovery in Patients With Stroke by Enhancing Cerebellar-cortical Plasticity: a Randomized Double Blinded Controlled Repetitive TMS Trial
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : October 1, 2017

Arm Intervention/treatment
Active Comparator: Cerebellar iTBS
Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability

Sham Comparator: Sham iTBS
Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability




Primary Outcome Measures :
  1. Berg Balance Scale (BBS) for gait and balance [ Time Frame: Change from baseline at the end of three weeks treatment ]
    Assessment of gait and balance functions


Secondary Outcome Measures :
  1. Fugl-Meyer Assessment (FMA) scale [ Time Frame: Change from baseline at the end of three weeks treatment ]
    Assessment of motor functions

  2. Barthel Index (BI) [ Time Frame: Change from baseline at the end of three weeks treatment ]
    Assessment of functional abilities

  3. Neurophysiological assessment of cortical activity [ Time Frame: Change from baseline at the end of three weeks treatment ]
    evaluation of cortical activity by means of TMS in combination with EEG

  4. Gait analysis [ Time Frame: Change from baseline at the end of three weeks treatment ]
    evaluation of locomotion



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First ever-chronic ischemic stroke, i.e. at least 6 months after the stroke event,
  • Left or right subcortical or cortical lesion of the middle cerebral artery with medium-severity stroke NHISS <15 (All lesions must be documented by magnetic resonance imaging (T1- and T2-weighted images; 1.5T, GE scanners)
  • No contraindication to brain MRI
  • MEP recordable in order to evaluate the resting motor threshold (RMT)

Exclusion Criteria:

  • Epilepsy
  • Severe general impairment or concomitant diseases (tumors, etc.)
  • Age> 80 years
  • Infections in progress
  • Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the study.
  • Treatment with benzodiazepines, baclofen, antidepressants, clonidine, beta blockers and other potentially interfering drug treatments on plasticity phenomena.

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): NCT03456362


Locations
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Italy
Santa Lucia Foundation
Rome, Italy, 00179
Sponsors and Collaborators
I.R.C.C.S. Fondazione Santa Lucia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giacomo Koch, Head of Laboratory, I.R.C.C.S. Fondazione Santa Lucia
ClinicalTrials.gov Identifier: NCT03456362    
Other Study ID Numbers: RF-2011-02349953
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gait Disorders, Neurologic
Nervous System Diseases
Neurologic Manifestations