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Completed

NCT Number: NCT01333579

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Laboratório de Neuroestimulação, HC/FMUSP

São Paulo, 05403000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Repetitive transcranial magnetic stimulation

Other

Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. Force of the paretic hand

    Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment

  2. Fugl-Meyer evaluation of motor performance (upper limb)

    Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment

  3. Disability evaluated with the modified Rankin scale

    Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment

  4. Functional Independence Measure

    Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment

  5. Neurological impairment evaluated with the NIH Stroke Scale

    Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment

  6. Measures of corticomotor excitability evaluated with transcranial magnetic stimulation

    Time frame: Baseline, two weeks, 1 month, 3 and six months after end of treatment

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2011
Registry last updated
Sep 17, 2013

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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