Transcranial Direct Stimulation (tDCS) and Behavioral Intervention in Aphasia

NCT02226796 | Completed Results FDA Device

• 1 other identifier: 1506M73043
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize patients who have difficulty with word recall (naming pictures) due to a stroke will experience greater benefit in word recall after receiving a combination of transcranial direct current stimulation (tDCS) and traditional behavioral treatment. This study will investigate the effects of the timing of tDCS in relationship to the behavioral treatment to determine the most optimal protocol. Transcranial direct current stimulation involves placing two electrodes on your scalp and sending a very small electrical current to excite the brain cells of the target site.

Conditions

Aphasia

Keywords

Broca's Aphasia; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (2)

• Naming Reaction Time

  Participants are shown one or 3 possible banks of pictures balanced for phonemic complexity which are randomly assigned to prevent learning effect. Each bank contains 15 items. Time to recall is measured using a stop watch. The mean time to recall across all items is calculated and reported in milliseconds. The smaller the number, the faster / better the reaction time is.

  40 minutes

• Naming Accuracy

  Participants are shown one of 3 possible banks of pictures balanced for phonemic complexity which are randomly assigned to prevent learning effect. Each bank contains 15 items. Each trial is scored by an examiner as accurate (1) or inaccurate (0) based on articulatory accuracy of the participant's response. The average of all trials is calculated for each participant. Total scores range from 0-15 with higher scores indicating better naming accuracy/performance.

  40 minutes

Secondary Outcomes (3)

• Boston Naming Test

  30 minutes

• Western Aphasia Battery Total Score

  60 minutes

• Working Memory Total Score

  2 months

Study Arms (2)

Prime Condition

ACTIVE COMPARATOR

The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes to the dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.

Device: Transcranial direct current stimulation

Non-Prime Condition/Control

ACTIVE COMPARATOR

The non-primed (NON-PRIME) condition, or sham controlled, is an intervention that will consist of presentation of sham tDCS to the dorsolateral prefrontal cortex for 20 minutes prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation tool that presents a low current that induces bi-directional polarity-dependent changes in the cortex to facilitate focal, prolonged shifts in cortical excitability at or around the time stimulation is provided. Anodal tDCS (a-tDCS), in which the positively charged electrode is placed over the targeted cortical region, has been shown to increase cortical excitability (upregulation), similar to long-term potentiation (LTP). Combining a-tDCS with behavioral-based approaches has been suggested to enhance the learning process and increase the likelihood of retention.

Non-Prime Condition/Control; Prime Condition

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• completion of high school or GED, normal or corrected-to-normal vision, adequate hearing acuity for 1:1 conversational exchanges, use of English as primary language, a vascular lesion in the dominant left hemisphere verified by an MRI scan within six months of the start of the study

You may not qualify if:

• no previous history of neurological- or psychiatric-based illnesses or disease, language or learning disabilities, or alcohol/substance abuse; no history of seizures; no metal implants in the head (except dental fillings); no lesion in the left DLPFC confirmed by MRI; no current pregnancy.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Aphasia; Aphasia, Broca

Interventions

Transcranial Direct Current Stimulation

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)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Sharyl Samargia-Grivette
• Organization: University of Minnesota Duluth

samargia@d.umn.edu

218-726-8347

Study Officials

• Sharyl A Samargia, PhD

  University of Minnesota and University of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 27, 2014
• Study Start: September 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 18, 2022
• Results First Posted: February 18, 2021

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)