Low-frequency Transcranial Magnetic Stimulation To Enhance Motor Recovery In The Subacute Phase After Stroke

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Adriana Bastos Conforto, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01333579
First received: April 4, 2011
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected hemisphere (UH) transiently improves motor function in patients in the chronic phase after stroke. The goal of this study is to investigate effects on motor recovery of low-frequency rTMS of the UH, administered in the subacute phase after stroke.


Condition Intervention Phase
Stroke
Other: Repetitive transcranial magnetic stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-frequency Transcranial Magnetic Stimulation To Enhance Motor Recovery In The Subacute Phase After Stroke

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Motor function of the paretic hand evaluated with the Jebsen-Taylor test [ Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment ] [ Designated as safety issue: Yes ]
  • Number of patients able to comply with the protocol [ Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Force of the paretic hand [ Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment ] [ Designated as safety issue: No ]
  • Fugl-Meyer evaluation of motor performance (upper limb) [ Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment ] [ Designated as safety issue: No ]
  • Disability evaluated with the modified Rankin scale [ Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment ] [ Designated as safety issue: No ]
  • Functional Independence Measure [ Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment ] [ Designated as safety issue: No ]
  • Neurological impairment evaluated with the NIH Stroke Scale [ Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment ] [ Designated as safety issue: No ]
  • Measures of corticomotor excitability evaluated with transcranial magnetic stimulation [ Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: February 2008
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active rTMS
1Hz active rTMS delivered to the unaffected hemisphere
Other: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
Placebo Comparator: Placebo rTMS
1Hz placebo rTMS delivered to the vertex
Other: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.

Detailed Description:

Stroke is a major cause of disability and worldwide. Hand motor impairment is frequent after stroke. Even mild impairments of the upper limb negatively impact disability and quality of life in these patients significantly contributes to disability. Therapeutic alternatives for hand motor rehabilitation are deeply needed.

Repetitive transcranial magnetic stimulation (rTMS) has emerged as a potential tool to improve hand motor performance after stroke. While high-frequency rTMS (HF-rTMS) often increases motor cortical excitability, LF-rTMS often has the opposite effect. Up-regulation of excitability in the affected hemisphere by HF-rTMS or down-regulation of the UH by LF-rTMS can restore the balance in inter-hemispheric inhibition and hence, facilitate movement of the paretic hand Both strategies, as well as the combination of both, have yielded encouraging results when applied in proof-of-principle, single-session studies to patients with mild hand motor impairment in the subacute and chronic stages after stroke. However, few rTMS studies included patients less than six months after stroke, and effects of LF-rTMS of the unaffected hemisphere in patients with severe motor impairment in the subacute phase have not been yet reported.

The investigators opted for a novel approach to enhance hand motor recovery, by examining feasibility, safety and preliminary efficacy of either active or sham LF-rTMS of the UH or sham rTMS as add-on therapies to outpatient customary rehabilitation, to patients with mild to severe hand paresis, within 5-45 days after unilateral ischemic stroke. The investigators hypothesize that, at this stage, LF-rTMS will be feasible even in patients with severe motor deficits, will have minimal adverse events and will enhance effects of customary rehabilitation on hand motor performance.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First-ever ischemic stroke in the internal carotid artery territory confirmed by CT or MRI, 5-45 days before, leading to contralateral hand weakness
  • Age, 18-80 years

Exclusion Criteria:

  • Cardiac pacemaker
  • Pregnancy
  • Implantable medication pump
  • Intracranial hypertension
  • History of seizures
  • Metal in the head
  • Decompressive surgery
  • Other neurological diseases
  • Shoulder pain
  • Joint deformity in the paretic upper limb
  • Severe chronic disease such as end-stage cancer or end-stage renal failure
  • Inability to provide informed consent due to severe language or cognitive impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333579

Locations
Brazil
Laboratório de Neuroestimulação, HC/FMUSP
São Paulo, SP, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Adriana Conforto, MD, PhD HC/FMUSP/Fundação Faculdade de Medicina
  More Information

No publications provided by University of Sao Paulo General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adriana Bastos Conforto, Professor and Neurologist, Neurostimulation Laboratory, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01333579     History of Changes
Other Study ID Numbers: NCT2006/55504-0
Study First Received: April 4, 2011
Last Updated: September 16, 2013
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014