Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke

NCT ID: NCT02422173

Last Updated: 2015-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-04-30

Brief Summary

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Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.

Detailed Description

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This is a randomized sham-controlled trial reported following the 2010 CONSORT guidelines. The subjects were randomly allocated into 1 of 4 groups in a double-blinded parallel study design. Each patient received 10 sessions (5 consecutive days for 2 weeks) of real or sham stimulation at 2 mA intensity and current density equivalent to 0.05 A/m2.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anodal tDCS

Participants in the acute post-stroke stage will receive anodal transcranial direct current stimulation

Group Type EXPERIMENTAL

Anodal transcranial direct current stimulation

Intervention Type DEVICE

The active electrode is placed on the affected hemisphere

Cathodal tDCS

Participants in the acute post-stroke stage will receive cathodal transcranial direct current stimulation

Group Type EXPERIMENTAL

Cathodal transcranial direct current stimulation

Intervention Type DEVICE

The active electrode is placed on the unaffected hemisphere

Bilateral tDCS

Participants in the acute post-stroke stage will receive bilateral transcranial direct current stimulation

Group Type EXPERIMENTAL

Bilateral transcranial direct current stimulation

Intervention Type DEVICE

The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.

Sham tDCS

Participants in the acute post-stroke stage will receive sham transcranial direct current stimulation

Group Type SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type DEVICE

Placebo stimulation, with emission current by only 30 seconds

Interventions

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Anodal transcranial direct current stimulation

The active electrode is placed on the affected hemisphere

Intervention Type DEVICE

Cathodal transcranial direct current stimulation

The active electrode is placed on the unaffected hemisphere

Intervention Type DEVICE

Bilateral transcranial direct current stimulation

The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.

Intervention Type DEVICE

Sham transcranial direct current stimulation

Placebo stimulation, with emission current by only 30 seconds

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of acute stroke
* Able to walk 10m independently
* High risk of falling

Exclusion Criteria

* Severe functional limitations
* Cognitive impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of ParaĆ­ba

OTHER

Sponsor Role lead

Responsible Party

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Suellen Marinho Andrade

Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

Reference Type DERIVED
PMID: 33175411 (View on PubMed)

Other Identifiers

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tdcs002

Identifier Type: -

Identifier Source: org_study_id

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