Transcranial Direct Current Stimulation in Post-stroke Fatigue

Stroke Clinical Trial

— TIPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04634864
• Other study ID #: 195246
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: August 8, 2019

Study information

• Verified date: November 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 8, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Stroke

Intervention

Device:
• Anodal tDCS
40 minutes of 2mA intensity direct current stimulation was delivered over both the right and left motor cortex simultaneously
• sham tDCS
The stimulator was switched off after 2 minutes of stimulation.

Locations

Country	Name	City	State
United Kingdom	33 Queen Square, Institute of Neurology, UCL	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale - 7	a questionnaire based fatigue scale	2 weeks
Secondary	Resting Motor Threshold	This is a measure of cortical excitability as measured by transcranial magnetic stimulation	1 day
Secondary	Input-output curves	This is a measure of cortical recruitment as measured by transcranial magnetic stimulation	1 day
Secondary	Perceived effort - Explicit	A VAS scale associated with a grip task	1 day
Secondary	Perceived effort - Implicit	A novel line length estimation task	1 day