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TIPS: Transcranial Direct Current Stimulation in Post-stroke Fatigue

Sponsor
University College, London (Other)
Overall Status
Completed
CT.gov ID
NCT04634864
Collaborator
(none)
33
Enrollment
1
Location
2
Arms
18.9
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Anodal tDCS
  • Device: sham tDCS
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
tDCS in Post-stroke Fatigue: a Double Blind, Sham-controlled, Bilateral Anodal Motor Cortical Stimulation Study
Actual Study Start Date :
Jan 10, 2018
Actual Primary Completion Date :
Aug 8, 2019
Actual Study Completion Date :
Aug 8, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anodal tDCS

40 minutes of 2mA intensity direct current stimulation

Device: Anodal tDCS
40 minutes of 2mA intensity direct current stimulation was delivered over both the right and left motor cortex simultaneously
Sham Comparator: sham tDCS

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
The stimulator was switched off after 2 minutes of stimulation.

Outcome Measures

Primary Outcome Measures

  1. Fatigue Severity Scale - 7 [2 weeks]

    a questionnaire based fatigue scale

Secondary Outcome Measures

  1. Resting Motor Threshold [1 day]

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

  2. Input-output curves [1 day]

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

  3. Perceived effort - Explicit [1 day]

    A VAS scale associated with a grip task

  4. Perceived effort - Implicit [1 day]

    A novel line length estimation task

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 33 Queen Square, Institute of Neurology, UCL London United Kingdom WC1N 3BG

Sponsors and Collaborators

  • University College, London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College, London
ClinicalTrials.gov Identifier:
NCT04634864
Other Study ID Numbers:
  • 195246
First Posted:
Nov 18, 2020
Last Update Posted:
Nov 18, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Stroke
Fatigue

Study Results

No Results Posted as of Nov 18, 2020