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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratório de Neuroestimulação, HC/FMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active rTMS

Placebo rTMS

Arm Description

1Hz active rTMS delivered to the unaffected hemisphere

1Hz placebo rTMS delivered to the vertex

Outcomes

Primary Outcome Measures

Motor function of the paretic hand evaluated with the Jebsen-Taylor test
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of patients able to comply with the protocol

Secondary Outcome Measures

Force of the paretic hand
Fugl-Meyer evaluation of motor performance (upper limb)
Disability evaluated with the modified Rankin scale
Functional Independence Measure
Neurological impairment evaluated with the NIH Stroke Scale
Measures of corticomotor excitability evaluated with transcranial magnetic stimulation

Full Information

First Posted
April 4, 2011
Last Updated
September 16, 2013
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01333579
Brief Title
Low-frequency Transcranial Magnetic Stimulation To Enhance Motor Recovery In The Subacute Phase After Stroke
Official Title
Low-frequency Transcranial Magnetic Stimulation To Enhance Motor Recovery In The Subacute Phase After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS
Arm Type
Active Comparator
Arm Description
1Hz active rTMS delivered to the unaffected hemisphere
Arm Title
Placebo rTMS
Arm Type
Placebo Comparator
Arm Description
1Hz placebo rTMS delivered to the vertex
Intervention Type
Other
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
Primary Outcome Measure Information:
Title
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
Title
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
Title
Number of patients able to comply with the protocol
Time Frame
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Secondary Outcome Measure Information:
Title
Force of the paretic hand
Time Frame
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Title
Fugl-Meyer evaluation of motor performance (upper limb)
Time Frame
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Title
Disability evaluated with the modified Rankin scale
Time Frame
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Title
Functional Independence Measure
Time Frame
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Title
Neurological impairment evaluated with the NIH Stroke Scale
Time Frame
Baseline, two weeks, 1 month, 3 and six months after end of treatment
Title
Measures of corticomotor excitability evaluated with transcranial magnetic stimulation
Time Frame
Baseline, two weeks, 1 month, 3 and six months after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Conforto, MD, PhD
Organizational Affiliation
HC/FMUSP/Fundação Faculdade de Medicina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratório de Neuroestimulação, HC/FMUSP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24643406
Citation
Anjos SM, Cohen LG, Sterr A, de Andrade KN, Conforto AB. Translational neurorehabilitation research in the third world: what barriers to trial participation can teach us. Stroke. 2014 May;45(5):1495-7. doi: 10.1161/STROKEAHA.113.003572. Epub 2014 Mar 18.
Results Reference
derived

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

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