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

September 16, 2013 updated by: Adriana Bastos Conforto, University of Sao Paulo General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403000
        • Laboratório de Neuroestimulação, HC/FMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, two weeks, 1 month, 3 and six months after end of treatment
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
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Number of patients able to comply with the protocol
Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Baseline, two weeks, 1 month, 3 and six months after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Force of the paretic hand
Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Fugl-Meyer evaluation of motor performance (upper limb)
Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Disability evaluated with the modified Rankin scale
Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Functional Independence Measure
Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Neurological impairment evaluated with the NIH Stroke Scale
Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Measures of corticomotor excitability evaluated with transcranial magnetic stimulation
Time Frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment
Baseline, two weeks, 1 month, 3 and six months after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Adriana Conforto, MD, PhD, HC/FMUSP/Fundação Faculdade de Medicina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 11, 2011

First Posted (Estimate)

April 12, 2011

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT2006/55504-0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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