Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia

NCT03510182 | Completed Results DMC FDA Device

• 1 other identifier: HUM00108213
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS with intensive language therapy as a way of enhancing language outcomes in aphasia

Conditions

Aphasia

Outcome Measures

Primary Outcomes (2)

• Change in Controlled Oral Word Fluency

  This test assesses the number of words that can be generated in one minute that begin with certain letters. The total number of words generated for three letters is derived. Higher scores represent better performance. Changes in word fluency were calculated as follows: number of words generated post tDCS minus number of words generated pre tDCS

  baseline and 4 weeks

• Change in Boston Naming Score

  This test assesses confrontational naming ability to 60 line drawings. Scores range from 0-60 with higher scores representing better performance. Outcome was derived as followed : Picture naming score post tDCS minus picture naming score pre tDCS

  baseline and 4 weeks

Secondary Outcomes (1)

• Change in Western Aphasia Quotient Score

  baseline and 4 weeks

Study Arms (1)

transcranial Direct Current Stimulation

EXPERIMENTAL

tDCS will be given to all qualified patients with aphasia.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

transcranial Direct Current Stimulation

Eligibility Criteria

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

You may qualify if:

• Diagnosis of aphasia
• Enrolled in intensive therapy program at the University of Michigan Aphasia Program.
• Ability to understand and give consent to treatment.

You may not qualify if:

• No metal implants or surgical devices
• History of seizures
• History of significant cognitive or psychiatric disturbance
• Participant cannot be pregnant at the time of study

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University Center for Language and Literacy

Ann Arbor, Michigan, 48194, United States

Location

MeSH Terms

Conditions

Aphasia

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: Carol Persad
• Organization: University of Michigan

cpersad@umich.edu

734-615-8112

Study Officials

• Carol Persad, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All eligible participants with aphasia will receive the tDCS

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 27, 2018
• Study Start: December 15, 2016
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: September 20, 2021
• Results First Posted: September 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)