tDCS as an Adjuvant to Intensive Speech Therapy for Chronic Post Stroke Aphasia

NCT02801864 | Unknown

• 1 other identifier: 2015-05-0071
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if transcranial direct current stimulation (tDCS) in conjunction with intensive speech therapy will improve sentence production and word retrieval in individuals with chronic post stroke aphasia.

Conditions

Aphasia; Language

Keywords

tDCS; transcranial direct current stimulation; intensive speech therapy; chronic; post stroke; aphasia; production; language

Outcome Measures

Primary Outcomes (3)

• Improvement in naming nouns as measured by Object Naming Test

  Nouns will be tested using An Object Naming Test by Dr.Judith Druks and Dr.Jackie Masterson

  After eight weeks of treatment

• Improvement in naming Action verbs as measured by Northwestern Assessment Verbs Sentences

  naming Action Verbs will be measured using Northwestern Assessment of Verbs(NAVS)

  After eight weeks of treatment

• Improvement in sentence production as measured by NAVS

  Sentence production will be measured using Northwestern Assessment of Verbs and Sentences(NAVS)

  After eight weeks of treatment

Secondary Outcomes (1)

• Improvement in picture description as measured by Western Aphasia Battery

  After eight weeks of treatment

Study Arms (2)

Combined real tDCS + IST

EXPERIMENTAL

Participants will receive tDCS via a Starstim device at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. The stimulation will be ramped up for 45 seconds and ramped down for 15 seconds. For the experimental group, the stimulation will be ramped up for 45 seconds and stay there for 20 min. The participants will receive three weeks of tDCS and continue receiving only intensive speech therapy for five weeks for three hours a day.

Device: Real tDCS; Other: Intensive Speech Therapy

Combined sham tDCS + IST

SHAM COMPARATOR

Participants will receive tDCS via a Starstim device at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. For the sham group, the stimulation will be ramped up for 45 seconds and ramped down for 15 seconds. The stimulation will be ramped up for 45 seconds and then ramp down after the initial 45 seconds. The participants will receive three weeks of tDCS and continue receiving only intensive speech therapy for five weeks for three hours a day.

Device: Sham tDCS; Other: Intensive Speech Therapy

Interventions

Real tDCS DEVICE

Participants will receive tDCS at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. Stimulation will be provided via an electrode using a Starstim device.

Combined real tDCS + IST

Sham tDCS DEVICE

Participants will receive tDCS at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. Stimulation will be provided via an electrode using a Starstim device.

Combined sham tDCS + IST

Intensive Speech Therapy OTHER

Participants will receive one hour of group therapy and two hours of individual therapy that will follow VNeST format. The purpose of therapy will be to have the client generate verbs and nouns in written and verbal form.

Combined real tDCS + IST; Combined sham tDCS + IST

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have suffered a left CVA
• Demonstrate 50% or greater on the Auditory Verbal Comprehension section of the WAB

You may not qualify if:

• Have any other type of neurological condition
• Have any other medical conditions, such as seizures or implants
• Have suffered a right CVA
• Are receiving teletherapy

Sponsors & Collaborators

• Austin Speech Labs: lead
• Burke Medical Research Institute: collaborator
• University of Texas: collaborator

Study Sites (1)

Austin Speech Labs

Austin, Texas, 78757, United States

Location

Related Publications (6)

• Monti A, Ferrucci R, Fumagalli M, Mameli F, Cogiamanian F, Ardolino G, Priori A. Transcranial direct current stimulation (tDCS) and language. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):832-42. doi: 10.1136/jnnp-2012-302825. Epub 2012 Nov 8.

  PMID: 23138766 BACKGROUND

• Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.

  PMID: 15753425 BACKGROUND

• Fertonani A, Rosini S, Cotelli M, Rossini PM, Miniussi C. Naming facilitation induced by transcranial direct current stimulation. Behav Brain Res. 2010 Apr 2;208(2):311-8. doi: 10.1016/j.bbr.2009.10.030. Epub 2009 Oct 31.

  PMID: 19883697 BACKGROUND

• de Vries MH, Barth AC, Maiworm S, Knecht S, Zwitserlood P, Floel A. Electrical stimulation of Broca's area enhances implicit learning of an artificial grammar. J Cogn Neurosci. 2010 Nov;22(11):2427-36. doi: 10.1162/jocn.2009.21385.

  PMID: 19925194 BACKGROUND

• Holland R, Leff AP, Josephs O, Galea JM, Desikan M, Price CJ, Rothwell JC, Crinion J. Speech facilitation by left inferior frontal cortex stimulation. Curr Biol. 2011 Aug 23;21(16):1403-7. doi: 10.1016/j.cub.2011.07.021. Epub 2011 Aug 4.

  PMID: 21820308 BACKGROUND

• Wirth M, Rahman RA, Kuenecke J, Koenig T, Horn H, Sommer W, Dierks T. Effects of transcranial direct current stimulation (tDCS) on behaviour and electrophysiology of language production. Neuropsychologia. 2011 Dec;49(14):3989-98. doi: 10.1016/j.neuropsychologia.2011.10.015. Epub 2011 Oct 21.

  PMID: 22044650 BACKGROUND

MeSH Terms

Conditions

Aphasia; Language; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication; Behavior; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Thomas Marquardt, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Shilpa Shamapant, M.S.,M.A.

  Austin Speech Labs

  PRINCIPAL INVESTIGATOR

• Dylan Edwards, Ph.D.

  Burke Medical Rehabilitation and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: June 16, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: July 2, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)