Cerebellar rTMS to Improve Gait Recovery

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456362
• Other study ID #: RF-2011-02349953
• Status: Completed
• Phase: N/A
• First received: February 19, 2018
• Last updated: March 5, 2018
• Start date: March 1, 2014
• Est. completion date: October 1, 2017

Study information

• Verified date: March 2018
• Source: I.R.C.C.S. Fondazione Santa Lucia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Stroke

Intervention

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

Locations

Country	Name	City	State
Italy	Santa Lucia Foundation	Rome

Sponsors (1)

Lead Sponsor	Collaborator
I.R.C.C.S. Fondazione Santa Lucia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fugl-Meyer Assessment (FMA) scale	Assessment of motor functions	Change from baseline at the end of three weeks treatment
Secondary	Barthel Index (BI)	Assessment of functional abilities	Change from baseline at the end of three weeks treatment
Secondary	Neurophysiological assessment of cortical activity	evaluation of cortical activity by means of TMS in combination with EEG	Change from baseline at the end of three weeks treatment
Secondary	Gait analysis	evaluation of locomotion	Change from baseline at the end of three weeks treatment