Effects of Transcranial Direct Current Stimulation in Post-stroke Aphasia

NCT02622945 | Withdrawn DMC

• 1 other identifier: NA00078932
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether transcranial direct current stimulation (tDCS) paired with speech-language therapy is more beneficial than speech-language therapy alone in acute and chronic post-stroke aphasia.

Conditions

Aphasia

Outcome Measures

Primary Outcomes (1)

• Change in picture naming scores in trained and untrained items

  Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups

Secondary Outcomes (4)

• Change in Philadelphia Naming Test: Picture naming of everyday objects, different from training set

  Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups

• Change in Written naming of objects and actions

  Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups

• Change in working memory (digit span)

  Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups

• Change in verbal fluency

  Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups

Study Arms (2)

Active tDCS plus Speech-Language Therapy

EXPERIMENTAL

Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.

Device: Active tDCS plus Speech-Language Therapy

Sham plus Speech-Language Therapy

SHAM COMPARATOR

Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.

Device: Sham plus Speech-Language Therapy

Interventions

Active tDCS plus Speech-Language Therapy DEVICE

Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain not affected by the lesion(perilesional areas, right hemisphere or cerebellum). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.

Also known as: Active tDCS and speech-therapy

Active tDCS plus Speech-Language Therapy

Sham plus Speech-Language Therapy DEVICE

Speech-Language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.

Also known as: Sham tDCS plus speech-therapy

Sham plus Speech-Language Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed with with post-stroke aphasia and word-retrieval deficits
• Premorbid speakers of English
• Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment
• Stroke size: any l
• Location: Left hemisphere strokes only from any etiology.
• Time since stroke onset: 1 day to 20 years.

You may not qualify if:

• uncorrected visual or hearing impairment by self report
• other premorbid neurological disorder affecting the brain
• any other language-based learning disorder or other neurodegenerative disorder such as Alzheimer's Disease or Primary Progressive Aphasia
• premorbidly diagnosed with a developmental language disorder
• Pregnant women will also be excluded

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.

  PMID: 21842404 BACKGROUND

• Dmochowski JP, Datta A, Huang Y, Richardson JD, Bikson M, Fridriksson J, Parra LC. Targeted transcranial direct current stimulation for rehabilitation after stroke. Neuroimage. 2013 Jul 15;75:12-19. doi: 10.1016/j.neuroimage.2013.02.049. Epub 2013 Mar 5.

  PMID: 23473936 BACKGROUND

MeSH Terms

Conditions

Aphasia

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: December 7, 2015
• Study Start: February 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

US (1)