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CompletedNCT02628561Updated Apr 5, 2016

Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke

A Phase 1/2 interventional study of Transcranial direct current stimulation and Constraint-Induced Movement Therapy in Stroke, Cerebrovascular Disorders and Cerebral Infarction, sponsored by Federal University of Paraíba. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-04-05.

Sponsored by Federal University of Paraíba · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.

Read the detailed description

Stroke survivors experience one or more movement-related impairments and activity limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents evidence of good therapeutic results. The investigators hypothesized that applying tDCS and CIMT over the PMC promotes motor restoration in stroke patients.

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Conditions studied

  • Stroke
  • Cerebrovascular Disorders
  • Cerebral Infarction
03

In context

Cerebral Infarction

813 studies on the registry are indexed under Cerebral Infarction; 181 are open to participants now.

This study's enrollment of 60 is below the median of 120 across 532 interventional studies indexed under Cerebral Infarction.

Browse Cerebral Infarction studies →

Lead sponsor

Federal University of Paraíba is the lead sponsor of 72 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 18 and 65 years
  • Diagnosis of unilateral, non-recurring, subacute stroke
  • Participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it.

Exclusion criteria

Exclusion Criteria:

  • Patients with difficulty to follow the procedures or understand the instructions; cognitive deficits
  • tDCS criteria:

    • use of modulators of the Central Nervous System drugs
    • patients with implanted metallic or electronic devices
    • pacemaker
    • seizures
    • pregnancy
    • any other condition that might limit or interfere in the sensorimotor system
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Active tdcs/M1

    Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)

    Device: Transcranial direct current stimulation · Behavioral: Constraint-Induced Movement Therapy

  • Experimental
    Active tdcs/Premotor

    Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)

    Device: Transcranial direct current stimulation · Behavioral: Constraint-Induced Movement Therapy

  • Sham comparator
    Sham tdcs

    Sham tDCS and CIMT (constraint induced movement therapy)

    Device: Transcranial direct current stimulation · Behavioral: Constraint-Induced Movement Therapy

Interventions

  • DeviceTranscranial direct current stimulation
  • BehavioralConstraint-Induced Movement Therapy
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What researchers measure

Primary outcomes

  1. Functional Independence measured by Barthel Index

    Time frame: Change for functional independence at baseline and week 2

Secondary outcomes

  1. Spasticity (Modified Ashworth Scale)

    Time frame: Baseline and Week 2

  2. Muscle strength (Medical Research Council Scale)

    Time frame: Baseline and Week 2

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Study locations

1 site
  • Suellen Andrade
    João Pessoa, PB, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02628561
Lead sponsor
Federal University of Paraíba
Responsible party
Suellen Marinho Andrade (PhD, Federal University of Paraíba) — Principal investigator
First posted
Dec 11, 2015
Start date
Jan 2016
Primary completion
Feb 2016
Completion
Apr 2016
Last update
Apr 5, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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