Transcranial Direct Current Stimulation in Post-stroke Fatigue

NCT ID: NCT04634864

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2019-08-08

Brief Summary

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

Detailed Description

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Conditions

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Fatigue Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Anodal tDCS

40 minutes of 2mA intensity direct current stimulation

Group Type ACTIVE_COMPARATOR

Anodal tDCS

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

The stimulator was switched off after 2 minutes of stimulation.

Interventions

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Anodal tDCS

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

Intervention Type DEVICE

sham tDCS

The stimulator was switched off after 2 minutes of stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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33 Queen Square, Institute of Neurology, UCL

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33598767 (View on PubMed)

Other Identifiers

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195246

Identifier Type: -

Identifier Source: org_study_id