NCT04138433

Brief Summary

Most of us take being able to communicate for granted. Anomia (word finding problems) after stroke can cause profound frustration and anxiety for patients and families. Some people recover; many don't. \~ 250,000 people in the UK have chronic speech and language problems post-stroke. This project will investigate how treatment for these people might be improved. The brain's speech areas can be stimulated using transcranial direct current stimulation (tDCS). The kit is simple; a battery powering electrodes placed on the scalp. Healthy people who had tDCS while naming pictures could find words quicker and their speech areas responded more efficiently. How it affects aphasic stroke patients' brain function is unknown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

October 24, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

4.2 years

First QC Date

October 24, 2016

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Naming Speed

    change in Tailor-made object naming test,

    change from baseline to 20 minutes during and 20 minutes post tDCS intervention

Secondary Outcomes (1)

  • Higher accuracy in naming

    change from baseline to 20 minutes during and 20 minutes post tDCS intervention

Study Arms (2)

Real tDCS

EXPERIMENTAL

fMRI task plus anodal tDCS

Device: Real tDCS

Sham tDCS

SHAM COMPARATOR

fMRI task plus sham tDCS

Device: Sham tDCS

Interventions

Real tDCSDEVICE

Anodal tDCS 2 ma

Also known as: Brain Stimulation
Real tDCS
Sham tDCSDEVICE

Sham tDCS 2 ma

Also known as: Brain Stimulation
Sham tDCS

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English native speakers
  • Over the age of 18
  • months or more after aphasic stroke
  • Able to provide informed consent

You may not qualify if:

  • Significant medical or psychiatric co-morbidity
  • Clinical or neuroimaging evidence of significant multifocal cerebral disease
  • Contraindications to tdcs
  • Contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cognitive Neuroscience, University College London

London, Greater London, WC1N 3AZ, United Kingdom

Location

MeSH Terms

Conditions

Anomia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Jennifer Crinion, Dr

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jennifer Crinion

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 24, 2019

Study Start

November 30, 2017

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations