Transcranial Direct Current Stimulation Acute Stroke Walking

NCT ID: NCT04349488

Last Updated: 2020-04-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-16

Study Completion Date

2020-06-30

Brief Summary

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16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham.

Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week.

Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks.

The evaluations are the Four Square Step Test, the Berg Balance Scale, the Postural Assessment Scale For Stroke, the Trunk Impairment Scale, the Time Up \& Go and the 10 meter walking test.

Detailed Description

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Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group receives anodal tDCS, one placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

Anode placed over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Group Type ACTIVE_COMPARATOR

Anodal Transcranial Direct Current Stimulation

Intervention Type DEVICE

Subjects received a micro-current through their scalp to induce cortical and subcortical changes

Placebo

Anode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Group Type PLACEBO_COMPARATOR

Anodal Transcranial Direct Current Stimulation

Intervention Type DEVICE

Subjects received a micro-current through their scalp to induce cortical and subcortical changes

Interventions

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Anodal Transcranial Direct Current Stimulation

Subjects received a micro-current through their scalp to induce cortical and subcortical changes

Intervention Type DEVICE

Other Intervention Names

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tDCS

Eligibility Criteria

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Inclusion Criteria

* First Ever Stroke
* Motor or sensory deficit
* Understands and follows orders
* Signed inform consent

Exclusion Criteria

• One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Bornheim Stephen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Liege Univeristy Hospital

Liège, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Stephen Bornheim, Msc

Role: CONTACT

003243662193

Facility Contacts

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Stephen Bornheim, Msc

Role: primary

References

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Bornheim S, Croisier JL, Maquet P, Kaux JF. Proposal of a New Transcranial Direct Current Stimulation Safety Screening Tool. Am J Phys Med Rehabil. 2019 Jul;98(7):e77-e78. doi: 10.1097/PHM.0000000000001096. No abstract available.

Reference Type BACKGROUND
PMID: 30431445 (View on PubMed)

Other Identifiers

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2016/287

Identifier Type: -

Identifier Source: org_study_id

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