tDCS: Brain Stimulation and Aphasia Treatment

• Sponsor: University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01686373
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH), Medical University of South Carolina (Other)
• Enrollment: 74
• Locations: 2
• Arms: 2
• Duration (Months): 66
• Patients Per Site: 37
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the changes in language processing of patients with chronic, post-stroke aphasia following the application of brain stimulation. The brain stimulation the investigators administer is called transcranial direct current stimulation (tDCS). It involves passing a weak electrical current through the brain between two electrodes in the form of damp sponges. One sponge will be placed over a specified area on the damaged left hemisphere, while the other sponge will be placed on the right scalp. Computer-controlled speech-language treatment will be administered during the application of tDCS.

Condition or Disease	Intervention/Treatment	Phase
Aphasia	Device: Activa Dose II Real tDCS; Device: Activa Dose II Sham tDCS	Phase 2

Detailed Description

Stroke is the leading cause of adult disability in the United States. Approximately one-third of all strokes result in acute language impairment (aphasia), with approximately one-fifth suffering from chronic aphasia. Unfortunately, the prognosis for moderate to severe chronic aphasia remains grim, as current behavioral treatment approaches usually offer only limited-to-modest benefit. Recent advancements in understanding the relationship between low current electrical brain stimulation and cortical plasticity suggest that the effect of behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct current stimulation (A-tDCS). Indeed, we have shown how A-tDCS can significantly boost the effect of behavioral aphasia treatment. Based on these results as well as our other studies aimed at understanding how favorable brain plasticity correlates with positive treatment outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility design. Consistent with the goals of Program Announcement PAR-08-204 by the National Institute on Deafness and Other Communication Disorders (NIDCD), we plan to "evaluate whether there is sufficient evidence of short term improvement in humans to justify a phase III trial."

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Transcranial Direct Current Stimulation and Aphasia Treatment Outcomes
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Activa Dose II Real tDCS Actual delivery of electrical stimulation	Device: Activa Dose II Real tDCS; 20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)
Placebo Comparator: Activa Dose II Sham tDCS Sham delivery of electrical stimulation	Device: Activa Dose II Sham tDCS; 20 minutes of sham stimulation per treatment day (15 total sessions)

Outcome Measures

Primary Outcome Measures

1. The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). [Immediately post-treatment]

   The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients must be willing and able to give informed consent.

2. Patients must be willing and able to comply with study requirements.

3. Patients must be between 25- and 80-years of age.

4. Patients must be native English speakers.

5. Patients must be pre-morbidly right-handed.

6. Patients must have sustained a one-time ischemic stroke in the left-hemisphere.

7. Patients must be greater than 6-months post-stroke.

8. Patients must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.

9. Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.).

10. Patients must achieve at least 65% accuracy on naming task during screening -

Exclusion Criteria:

1. History of brain surgery

2. Seizures during the previous 12 months

3. Sensitive scalp (per patient report)

4. Able to overtly name more than an average of 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3.

5. Unable to overtly name at least an average of 5 out of 80 items during the pre-treatment functional magnetic resonance imaging (fMRI) sessions during Visits 2 or

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425
2	University of South Carolina (USC)	Columbia	South Carolina	United States	29208

Sponsors and Collaborators

• University of South Carolina
• National Institute on Deafness and Other Communication Disorders (NIDCD)
• Medical University of South Carolina

Investigators

• Principal Investigator: Julius Fridriksson, PhD, Director

Study Documents (Full-Text)

• Statistical Analysis Plan - Aug 29, 2012
• Study Protocol - Dec 20, 2018

More Information

Additional Information:

• University of South Carolina Aphasia Laboratory

Publications

None provided.

• Responsible Party: Julius Fridriksson, Professor, University of South Carolina
• ClinicalTrials.gov Identifier: NCT01686373
• Other Study ID Numbers: 11560FA12; U01DC011739
• First Posted: Sep 18, 2012
• Last Update Posted: Aug 20, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by Julius Fridriksson, Professor, University of South Carolina: Aphasia; Brain; Stimulation; Communication; Stoke; Post; Phase II Clinical Trial; Treatment; tDCS; Fridriksson
• Additional relevant MeSH terms: Aphasia

Study Results

Participant Flow

Arm/Group Title	Activa Dose II Real tDCS	Activa Dose II Sham tDCS
Arm/Group Description	Actual delivery of electrical stimulation Activa Dose II Real tDCS	Sham delivery of electrical stimulation Activa Dose II Sham tDCS
Period Title: Overall Study
STARTED	34	40
Received 15 Treatment Sessions	33	39
COMPLETED	31	38
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Activa Dose II Real tDCS	Activa Dose II Sham tDCS	Total
Arm/Group Description	Actual delivery of electrical stimulation Activa Dose II Real tDCS	Sham delivery of electrical stimulation Activa Dose II Sham tDCS	Total of all reporting groups
Overall Participants	34	40	74
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (11)	60 (10)	60 (10)
Sex: Female, Male (Count of Participants)
Female	10 29.4%	12 30%	22 29.7%
Male	24 70.6%	28 70%	52 70.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.9%	1 2.5%	2 2.7%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 17.6%	4 10%	10 13.5%
White	27 79.4%	35 87.5%	62 83.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	34 100%	40 100%	74 100%

Outcome Measures

1. Primary Outcome

Title	The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).
Description	The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.
Time Frame	Immediately post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Activa Dose II Real tDCS	Activa Dose II Sham tDCS
Arm/Group Description	Actual delivery of electrical stimulation Activa Dose II Real tDCS	Sham delivery of electrical stimulation Activa Dose II Sham tDCS
Measure Participants	34	40
Mean (95% Confidence Interval) [PNT and Naming 80 score]	13.9	8.2

Adverse Events

Time Frame	Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).
Arm/Group Title	Activa Dose II Real tDCS		Activa Dose II Sham tDCS
Arm/Group Description	Actual delivery of electrical stimulation Activa Dose II Real tDCS		Sham delivery of electrical stimulation Activa Dose II Sham tDCS
All Cause Mortality
	Activa Dose II Real tDCS		Activa Dose II Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/40 (0%)
Serious Adverse Events
	Activa Dose II Real tDCS		Activa Dose II Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		1/40 (2.5%)
Nervous system disorders
Convulsion	0/34 (0%)	0	1/40 (2.5%)	1
Other (Not Including Serious) Adverse Events
	Activa Dose II Real tDCS		Activa Dose II Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/34 (8.8%)		3/40 (7.5%)
Nervous system disorders
Dizziness	1/34 (2.9%)	1	2/40 (5%)	2
Headache	0/34 (0%)	0	1/40 (2.5%)	2
Skin and subcutaneous tissue disorders
Erythema	2/34 (5.9%)	2	0/40 (0%)	0
Vascular disorders
Hypertension	0/34 (0%)	0	1/40 (2.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.