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Completed

NCT Number: NCT04634864

Transcranial Direct Current Stimulation in Post-stroke Fatigue

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

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Key information

Conditions

Fatigue Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

33 Queen Square, Institute of Neurology, UCL

London, WC1N 3BG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with stroke at least 3 months post-stroke

Exclusion criteria

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

Treatment and study plan

Anodal tDCS

Device

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

Sham tDCS

Device

The stimulator was switched off after 2 minutes of stimulation.

Primary outcomes

  1. Fatigue Severity Scale - 7

    Time frame: 2 weeks

    a questionnaire based fatigue scale

Secondary outcomes

  1. Resting Motor Threshold

    Time frame: 1 day

    This is a measure of cortical excitability as measured by transcranial magnetic stimulation

  2. Input-output curves

    Time frame: 1 day

    This is a measure of cortical recruitment as measured by transcranial magnetic stimulation

  3. Perceived effort - Explicit

    Time frame: 1 day

    A VAS scale associated with a grip task

  4. Perceived effort - Implicit

    Time frame: 1 day

    A novel line length estimation task

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

tDCS in Post-stroke Fatigue: a Double Blind, Sham-controlled, Bilateral Anodal Motor Cortical Stimulation Study

Acronym: TIPS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 18, 2020
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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