NCT03456362

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

February 19, 2018

Last Update Submit

March 5, 2018

Conditions

StrokeGait, Hemiplegic

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale (BBS) for gait and balance

    Assessment of gait and balance functions

    Change from baseline at the end of three weeks treatment

Secondary Outcomes (4)

  • Fugl-Meyer Assessment (FMA) scale

    Change from baseline at the end of three weeks treatment

  • Barthel Index (BI)

    Change from baseline at the end of three weeks treatment

  • Neurophysiological assessment of cortical activity

    Change from baseline at the end of three weeks treatment

  • Gait analysis

    Change from baseline at the end of three weeks treatment

Study Arms (2)

Cerebellar iTBS

ACTIVE COMPARATOR

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

Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION

Sham iTBS

SHAM COMPARATOR

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

Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION

Interventions

REPETITIVE TRANSCRANIAL MAGNETIC STIMULATIONDEVICE

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

Cerebellar iTBSSham iTBS

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Lucia Foundation

Rome, 00179, Italy

Location

Related Publications (1)

  • 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.

    PMID: 30476999DERIVED

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Laboratory

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 7, 2018

Study Start

March 1, 2014

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

IT(1)