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Brain Stimulation and Aphasia Treatment (tDCS)

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ClinicalTrials.gov Identifier: NCT01686373
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Medical University of South Carolina
Information provided by (Responsible Party):
Julius Fridriksson, University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Aphasia
Interventions Device: Activa Dose II Real tDCS
Device: Activa Dose II Sham tDCS
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Activa Dose II Real tDCS Activa Dose II Sham tDCS
Hide 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
Reason Not Completed
Lost to Follow-up             3             0
Withdrawal by Subject             0             1
Adverse Event             0             1
Arm/Group Title Activa Dose II Real tDCS Activa Dose II Sham tDCS Total
Hide 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 Number of Baseline Participants 34 40 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 40 participants 74 participants
60  (11) 60  (10) 60  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 40 participants 74 participants
Female
10
  29.4%
12
  30.0%
22
  29.7%
Male
24
  70.6%
28
  70.0%
52
  70.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 40 participants 74 participants
American Indian or Alaska Native
1
   2.9%
1
   2.5%
2
   2.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  17.6%
4
  10.0%
10
  13.5%
White
27
  79.4%
35
  87.5%
62
  83.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 40 participants 74 participants
34 40 74
1.Primary Outcome
Title The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Activa Dose II Real tDCS Activa Dose II Sham tDCS
Hide Arm/Group Description:

Actual delivery of electrical stimulation

Activa Dose II Real tDCS

Sham delivery of electrical stimulation

Activa Dose II Sham tDCS

Overall Number of Participants Analyzed 34 40
Mean (95% Confidence Interval)
Unit of Measure: PNT and Naming 80 score
13.9
(9.0 to 18.7)
8.2
(3.8 to 12.6)
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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Activa Dose II Real tDCS Activa Dose II Sham tDCS
Hide 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 (%) Affected / at Risk (%)
Total   0/34 (0.00%)      0/40 (0.00%)    
Hide Serious Adverse Events
Activa Dose II Real tDCS Activa Dose II Sham tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      1/40 (2.50%)    
Nervous system disorders     
Convulsion * 1  0/34 (0.00%)  0 1/40 (2.50%)  1
1
Term from vocabulary, MedDRA (12.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Activa Dose II Real tDCS Activa Dose II Sham tDCS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/34 (8.82%)      3/40 (7.50%)    
Nervous system disorders     
Dizziness  1  1/34 (2.94%)  1 2/40 (5.00%)  2
Headache  1  0/34 (0.00%)  0 1/40 (2.50%)  2
Skin and subcutaneous tissue disorders     
Erythema  1  2/34 (5.88%)  2 0/40 (0.00%)  0
Vascular disorders     
Hypertension  1  0/34 (0.00%)  0 1/40 (2.50%)  1
1
Term from vocabulary, MedDRA (12.0)
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Julius Fridriksson
Organization: University of South Carolina
Phone: 1-803-777-5931
EMail: jfridrik@sc.edu
Layout table for additonal information
Responsible Party: Julius Fridriksson, University of South Carolina
ClinicalTrials.gov Identifier: NCT01686373    
Other Study ID Numbers: 11560FA12
U01DC011739 ( U.S. NIH Grant/Contract )
First Submitted: September 7, 2012
First Posted: September 18, 2012
Results First Submitted: April 17, 2019
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019