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Cerebellar rTMS to Improve Gait Recovery

Primary Purpose

Stroke, Gait, Hemiplegic

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Santa Lucia Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Cerebellar iTBS

Sham iTBS

Arm Description

Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.

Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.

Outcomes

Primary Outcome Measures

Berg Balance Scale (BBS) for gait and balance

Assessment of gait and balance functions

Secondary Outcome Measures

Fugl-Meyer Assessment (FMA) scale

Assessment of motor functions

Barthel Index (BI)

Assessment of functional abilities

Neurophysiological assessment of cortical activity

evaluation of cortical activity by means of TMS in combination with EEG

Gait analysis

evaluation of locomotion

Full Information

NCT ID

NCT03456362

First Posted

February 19, 2018

Last Updated

March 5, 2018

Sponsor

I.R.C.C.S. Fondazione Santa Lucia

1. Study Identification

Unique Protocol Identification Number

NCT03456362

Brief Title

Cerebellar rTMS to Improve Gait Recovery

Official Title

Promoting Motor Recovery in Patients With Stroke by Enhancing Cerebellar-cortical Plasticity: a Randomized Double Blinded Controlled Repetitive TMS Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

March 1, 2014 (Actual)

Primary Completion Date

June 1, 2017 (Actual)

Study Completion Date

October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Gait, Hemiplegic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cerebellar iTBS

Arm Type

Active Comparator

Arm Description

Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.

Arm Title

Sham iTBS

Arm Type

Sham Comparator

Arm Description

Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.

Intervention Type

Device

Intervention Name(s)

REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION

Intervention Description

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 Measure Information:

Title

Berg Balance Scale (BBS) for gait and balance

Description

Assessment of gait and balance functions

Time Frame

Change from baseline at the end of three weeks treatment

Secondary Outcome Measure Information:

Title

Fugl-Meyer Assessment (FMA) scale

Description

Assessment of motor functions

Time Frame

Change from baseline at the end of three weeks treatment

Title

Barthel Index (BI)

Description

Assessment of functional abilities

Time Frame

Change from baseline at the end of three weeks treatment

Title

Neurophysiological assessment of cortical activity

Description

evaluation of cortical activity by means of TMS in combination with EEG

Time Frame

Change from baseline at the end of three weeks treatment

Title

Gait analysis

Description

evaluation of locomotion

Time Frame

Change from baseline at the end of three weeks treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Santa Lucia Foundation

City

Rome

ZIP/Postal Code

00179

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

30476999

Citation

Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.

Results Reference

derived

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Cerebellar rTMS to Improve Gait Recovery

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