NCT01333579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1 stroke

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

4.4 years

First QC Date

April 4, 2011

Last Update Submit

September 16, 2013

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

  • Motor function of the paretic hand evaluated with the Jebsen-Taylor test

    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

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

  • Number of patients able to comply with the protocol

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

Secondary Outcomes (6)

  • Force of the paretic hand

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

  • Fugl-Meyer evaluation of motor performance (upper limb)

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

  • Disability evaluated with the modified Rankin scale

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

  • Functional Independence Measure

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

  • Neurological impairment evaluated with the NIH Stroke Scale

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

  • +1 more secondary outcomes

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

1Hz active rTMS delivered to the unaffected hemisphere

Other: Repetitive transcranial magnetic stimulation

Placebo rTMS

PLACEBO COMPARATOR

1Hz placebo rTMS delivered to the vertex

Other: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulationOTHER

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

Active rTMSPlacebo rTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratório de Neuroestimulação, HC/FMUSP

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 24643406DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Adriana Conforto, MD, PhD

    HC/FMUSP/Fundação Faculdade de Medicina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Neurologist, Neurostimulation Laboratory

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 12, 2011

Study Start

February 1, 2008

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

BR(1)