NCT04634864

Brief Summary

This is a double-blind, sham-controlled, anodal tDCS study to understand the effect of increasing motor cortex excitability on post-stroke fatigue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

November 12, 2020

Last Update Submit

November 17, 2020

Conditions

FatigueStroke

Outcome Measures

Primary Outcomes (1)

  • Fatigue Severity Scale - 7

    a questionnaire based fatigue scale

    2 weeks

Secondary Outcomes (4)

  • Resting Motor Threshold

    1 day

  • Input-output curves

    1 day

  • Perceived effort - Explicit

    1 day

  • Perceived effort - Implicit

    1 day

Study Arms (2)

Anodal tDCS

ACTIVE COMPARATOR

40 minutes of 2mA intensity direct current stimulation

Device: Anodal tDCS

sham tDCS

SHAM COMPARATOR

40 minutes of 0mA intensity. the session starts with a ramp up to 2mA, but machine is switched off after 2 minutes of stimulation.

Device: sham tDCS

Interventions

Anodal tDCSDEVICE

40 minutes of 2mA intensity direct current stimulation was delivered over both the right and left motor cortex simultaneously

Anodal tDCS
sham tDCSDEVICE

The stimulator was switched off after 2 minutes of stimulation.

sham tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with stroke at least 3 months post-stroke

You may not qualify if:

  • Other neurological conditions on Anti-depressants severe motor impairment (affected hand grip \<60% unaffected hand) severe cognitive impairment (unable to follow instructions, or give informed consent) scored \>11 in the depression sub-section of HADS questionnaire contraindications for TMS or tES

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

33 Queen Square, Institute of Neurology, UCL

London, WC1N 3BG, United Kingdom

Location

Related Publications (1)

  • De Doncker W, Ondobaka S, Kuppuswamy A. Effect of transcranial direct current stimulation on post-stroke fatigue. J Neurol. 2021 Aug;268(8):2831-2842. doi: 10.1007/s00415-021-10442-8. Epub 2021 Feb 17.

    PMID: 33598767DERIVED

MeSH Terms

Conditions

FatigueStroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 18, 2020

Study Start

January 10, 2018

Primary Completion

August 8, 2019

Study Completion

August 8, 2019

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

GB(1)