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Mechanisms Underlying Spoken Language Production

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04138433
Recruitment Status : Suspended (Due to COVID-19 - recruitment suspended since March 2020 in line with guidance from the UCLH/UCL Joint Research Office)
First Posted : October 24, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Jenny Crinion, University College, London

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.

This project will use functional brain-imaging techniques and new, high definition tDCS with anomia treatment in aphasic stroke patients. Brain stimulation (tDCS) paired with speech rehabilitation, may accelerate speech recovery. Participants will receive three weeks of speech training - more than they may get from the NHS. Given the gap between how much time NHS therapists can spend with patients (usually ~8-10 hours) and the amount of practice required to improve, a new approach enhancing speech therapy effectiveness is desirable. The main advantages of tDCS over drugs are its focal effects on the brain. It is also safe, portable, and relatively cheap. Moreover, with backing from a UK company that leads this specialised field, the project will develop a tDCS kit that people can use at home. Patients will practise naming pictures using the kit. The research will test whether speech improves after daily practice plus brain stimulation. MRI scans will measure how speech areas respond to training. It is hoped that identifying suitable candidates and offering this treatment may reduce the number of people living with chronic speech disability.


Condition or disease Intervention/treatment Phase
Aphasia, Anomic Device: Real tDCS Device: Sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Mechanisms Underlying Spoken Language Production: Facilitating Frontal Brain Networks Following Aphasic Stroke
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: Real tDCS
Behavioural anomia treatment plus anodal tDCS
Device: Real tDCS
Anodal tDCS 2 ma
Other Name: Brain Stimulation

Sham Comparator: Sham tDCS
Behavioural anomia treatment plus sham tDCS
Device: Sham tDCS
Sham tDCS 2 ma
Other Name: Brain Stimulation




Primary Outcome Measures :
  1. Change in Naming Speed [ Time Frame: change from baseline to directly post 3 week intervention ]
    change in Tailor-made object naming test, scores from the CAT


Secondary Outcome Measures :
  1. Higher accuracy in naming [ Time Frame: change from baseline to directly post 3 week intervention ]
    change in scores from CAT, tailor-made object naming tests

  2. Neuroplasticity [ Time Frame: change from baseline to directly post 3 week intervention ]
    change in structural MRI brain scan



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion criteria, subjects will be:

    1. English native speakers
    2. Over the age of 18
    3. 12 months or more after aphasic stroke
    4. Able to provide informed consent
  • Exclusion criteria, subjects will not have:

    1. Significant medical or psychiatric co-morbidity
    2. Clinical or neuroimaging evidence of significant multifocal cerebral disease
    3. Contraindications to tdcs
    4. Contraindications to MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138433


Locations
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United Kingdom
Institute of Cognitive Neuroscience, University College London
London, Greater London, United Kingdom, WC1N 3AZ
Sponsors and Collaborators
University College London Hospitals
Investigators
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Principal Investigator: Jennifer Crinion, Dr University College, London
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Responsible Party: Jenny Crinion, Professor Jennifer Crinion, University College, London
ClinicalTrials.gov Identifier: NCT04138433    
Other Study ID Numbers: 160106
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aphasia
Anomia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases