Back to results

Transcranial Direct Current Stimulation Acute Stroke Walking

Primary Purpose

Acute Stroke

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Anodal Transcranial Direct Current Stimulation

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Acute Stroke, tDCS, Anodal, Balance, Walking

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Liege Univeristy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes Four Square Step Test

The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The faster the score, the better the patients balance and coordination.

Changes Berg Balance Scale

Balance Test. Minimum score is 0, maximum 36. The higher the score, the better the balance.

Changes Postural Assessment Scale For Stroke

alance Test. Minimum score is 0, maximum 56. The higher the score, the better the balance.

Changes Trunk Impairment Scale

alance Test. Minimum score is 0, maximum 23. The higher the score, the better the balance.

Changes Time Up & Go

To determine fall risk and measure the progress of balance, sit to stand and walking. The faster, the better.

Changes 10 meter walking test

10 meter walking test, the faster the better

Secondary Outcome Measures

Full Information

NCT ID

NCT04349488

First Posted

April 13, 2020

Last Updated

April 23, 2020

Sponsor

University of Liege

1. Study Identification

Unique Protocol Identification Number

NCT04349488

Brief Title

Transcranial Direct Current Stimulation Acute Stroke Walking

Official Title

Transcranial Direct Current Stimulation Improves Walking and Balance in Acute Stroke Patients - a Randomized, Double-blind, Sham-controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 16, 2020 (Actual)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stroke

Keywords

Acute Stroke, tDCS, Anodal, Balance, Walking

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

One group receives anodal tDCS, one placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Anodal Transcranial Direct Current Stimulation

Other Intervention Name(s)

tDCS

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes Four Square Step Test

Description

The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The faster the score, the better the patients balance and coordination.

Time Frame