Comparing Transcranial Direct Current Stimulation Montages in Stroke

NCT04340973 | Unknown

• 1 other identifier: 2017-94
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Stroke

Keywords

tDCS; Acute Stroke; WMFT; SWMT; Fugl Meyer

Outcome Measures

Primary Outcomes (3)

• Change in Wolf Motor Function Test

  Functional upper limb test, filmed and scored subjectively

  Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

• Change in Fugl Meyer Motor Assessment

  Functional upper limb, lower limb and sensory test

  Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

• Change in Semmes Weinstein Monofilament Test

  11 Point Sensory test

  Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4

Study Arms (5)

Anodal

ACTIVE COMPARATOR

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

Device: Transcranial Direct Current Stimulation

Bilateral

ACTIVE COMPARATOR

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

Device: Transcranial Direct Current Stimulation

Cathodal

ACTIVE COMPARATOR

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

Device: Transcranial Direct Current Stimulation

Extracephalic

ACTIVE COMPARATOR

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

Device: Transcranial Direct Current Stimulation

Placebo

PLACEBO COMPARATOR

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

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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

Also known as: tDCS

Anodal; Bilateral; Cathodal; Extracephalic; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Liege Univeristy Hospital

Liège, 4000, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 30431445 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Stephen Bornheim, Msc

CONTACT

003243662193; stephen.bornheim@uliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Everyone is blinded, codes are selected by a third party not involved in any step of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 5 groups, each group receives one of four treatments or the sham treatment. Double-blinded, sham controlled study

Study Record Dates

• First Submitted: April 4, 2020
• First Posted: April 10, 2020
• Study Start: May 7, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

BE (1)