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Comparing Transcranial Direct Current Stimulation Montages in Stroke

Primary Purpose

Acute Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring tDCS, Acute Stroke, WMFT, SWMT, Fugl Meyer

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 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Anodal

Bilateral

Cathodal

Extracephalic

Placebo

Arm Description

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

Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks

Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder. 2 mA, 20min stimulation, 5 days a week for 4 weeks

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

Outcomes

Primary Outcome Measures

Change in Wolf Motor Function Test
Functional upper limb test, filmed and scored subjectively
Change in Fugl Meyer Motor Assessment
Functional upper limb, lower limb and sensory test
Change in Semmes Weinstein Monofilament Test
11 Point Sensory test

Secondary Outcome Measures

Full Information

First Posted
April 4, 2020
Last Updated
May 17, 2020
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04340973
Brief Title
Comparing Transcranial Direct Current Stimulation Montages in Stroke
Official Title
Comparing Different Transcranial Direct Current Stimulation Montages in Acute Stroke Patients: a Randomized, Triple-blinded, Sham-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
40 acute subjects will be split into 5 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal, extracephalic or placebo. 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. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test
Detailed Description
40 acute subjects will be randomized and split into 5 groups. Each group will receive one of the following tDCS montages : Anodal : Anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder Placebo : anode montage but current is ramped up over 15 secondes, then ramped down. Subjects will receive, in addition to conventional rehabilitation (±1.5h/weekday), 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. Evaluations consist of the Wolf Motor Function Test, the Fugl Meyer, and the Semmes Weinstein Monofilament Test All researchers, therapists, data analysis and patients are blinded by a code system implemented in the tDCS machine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
tDCS, Acute Stroke, WMFT, SWMT, Fugl Meyer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
5 groups, each group receives one of four treatments or the sham treatment. Double-blinded, sham controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Everyone is blinded, codes are selected by a third party not involved in any step of the study
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anodal
Arm Type
Active Comparator
Arm Description
Anodal tDCS: Anode placer 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
Bilateral
Arm Type
Active Comparator
Arm Description
Bilateral : Anode placer over the affected primary motor cortex, cathode over unaffected motor cortex. 2 mA, 20min stimulation, 5 days a week for 4 weeks
Arm Title
Cathodal
Arm Type
Active Comparator
Arm Description
Cathodal : Cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks
Arm Title
Extracephalic
Arm Type
Active Comparator
Arm Description
Extracephalic : Anode placer over the affected primary motor cortex, cathode over right shoulder. 2 mA, 20min stimulation, 5 days a week for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
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
Change in Wolf Motor Function Test
Description
Functional upper limb test, filmed and scored subjectively
Time Frame
Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Title
Change in Fugl Meyer Motor Assessment
Description
Functional upper limb, lower limb and sensory test
Time Frame
Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Title
Change in Semmes Weinstein Monofilament Test
Description
11 Point Sensory test
Time Frame
Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Bornheim, Msc
Phone
003243662193
Email
stephen.bornheim@uliege.be
Facility Information:
Facility Name
Liege Univeristy Hospital
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Bornheim, Msc

12. IPD Sharing Statement

Citations:
PubMed Identifier
30431445
Citation
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.
Results Reference
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Comparing Transcranial Direct Current Stimulation Montages in Stroke

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