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Completed

NCT Number: NCT03456362

Cerebellar rTMS to Improve Gait Recovery

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Gait, Hemiplegic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Lucia Foundation

Rome, 00179, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2018
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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