Trial Outcomes & Findings for Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia (NCT NCT03510182)

NCT ID: NCT03510182

Last Updated: 2021-09-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: baseline and 4 weeks
• Results posted on: 2021-09-20

Participant Flow

Participant milestones

Measure	Transcranial Direct Current Stimulation tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Transcranial Direct Current Stimulation tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Transcranial Direct Current Stimulation n=23 Participants tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Age, Continuous	35 years STANDARD_DEVIATION 11.7 • n=23 Participants
Sex: Female, Male Female	5 Participants n=23 Participants
Sex: Female, Male Male	18 Participants n=23 Participants
Boston Naming Test	5.94 units on a scale STANDARD_DEVIATION 5.97 • n=23 Participants
Controlled Oral Word Fluency	14.74 number of words STANDARD_DEVIATION 10.27 • n=23 Participants

PRIMARY outcome

Timeframe: baseline and 4 weeks

Population: 23 of the participants completed the study

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

Outcome measures

Measure	Transcranial Direct Current Stimulation n=23 Participants tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Change in Controlled Oral Word Fluency	3.1 number of words Standard Deviation 4.89

PRIMARY outcome

Timeframe: baseline and 4 weeks

Population: 23 of the 25 subjects completed the study and their data are analyzed here

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

Outcome measures

Measure	Transcranial Direct Current Stimulation n=23 Participants tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Change in Boston Naming Score	1.25 score Standard Deviation 3.96

SECONDARY outcome

Timeframe: baseline and 4 weeks

Population: 23 subjects completed the study and their data were analyzed

severity of aphasia is measured by the Western Aphasia Battery Revised. The Aphasia Quotient (AQ) score ranges from 0-100, with 100 being a perfect score. Change in the AQ was derived as follows : AQ post tDCS minus AQ pre tDCS

Outcome measures

Measure	Transcranial Direct Current Stimulation n=23 Participants tDCS will be given to all qualified patients with aphasia. transcranial direct current stimulation
Change in Western Aphasia Quotient Score	8.57 aphasia quotient score Standard Deviation 6.37

Adverse Events

Transcranial Direct Current Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carol Persad

University of Michigan

Phone: 734-615-8112

Email: cpersad@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place