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Cerebellar rTMS to Improve Gait Recovery

Sponsor
I.R.C.C.S. Fondazione Santa Lucia (Other)
Overall Status
Completed
CT.gov ID
NCT03456362
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
43
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
 N/A

Study Design

Study Type:
Interventional
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 :
Mar 1, 2014
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Berg Balance Scale (BBS) for gait and balance [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 [Change from baseline at the end of three weeks treatment]

    Assessment of motor functions

  2. Barthel Index (BI) [Change from baseline at the end of three weeks treatment]

    Assessment of functional abilities

  3. Neurophysiological assessment of cortical activity [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 [Change from baseline at the end of three weeks treatment]

    evaluation of locomotion

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Santa Lucia Foundation Rome Italy 00179

Sponsors and Collaborators

  • I.R.C.C.S. Fondazione Santa Lucia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Mar 7, 2018
Last Update Posted:
Mar 7, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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:
Gait Disorders, Neurologic

Study Results

No Results Posted as of Mar 7, 2018