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Evaluating Anodal tDCS Preceding Aphasia Therapy

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ClinicalTrials.gov Identifier: NCT02249819
Recruitment Status : Terminated
First Posted : September 26, 2014
Results First Posted : April 6, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stroke
Aphasia
Intervention Device: transcranial direct current stimulation
Enrollment 15
Recruitment Details  
Pre-assignment Details All participants received both the active and sham tDCS conditions, and sequence of stimulation conditions was randomized across participants.
Arm/Group Title Anodal tDCS, Then Sham tDCS Sham tDCS, Then Anodal tDCS
Hide Arm/Group Description Participants first received 1 single 20 min session of anodal tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of sham tDCS + computerized naming therapy. Participants first received 1 single 20 min session of sham tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of anodal tDCS + computerized naming therapy.
Period Title: Overall Study
Started 8 7
Completed 8 7
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Crossover design study: All participants were randomized to receive one single 20 min session of anodal tDCS and 1 single session of sham tDCS followed by computerized naming therapy. Sequence of stimulation conditions was counterbalanced across participants with a 1 week washout period in between conditions.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  53.3%
>=65 years
7
  46.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
7
  46.7%
Male
8
  53.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  13.3%
White
13
  86.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
1.Primary Outcome
Title Mean Change in Picture-naming Accuracy Score
Hide Description The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).
Time Frame baseline, discharge
Hide Outcome Measure Data
Hide Analysis Population Description
All participants received one dose of each intervention and completed all study visits. They were consequently all included in the efficacy analysis.
Arm/Group Title Anodal tDCS Sham tDCS
Hide Arm/Group Description:
Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy in either the first two or the last two weeks of the study.
Participants received 1 single 20 min session of sham tDCS + computerized naming therapy in either the first two or the last two weeks of the study.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: score
Mean Score at Discharge(out of 75) 51.33  (17.79) 51.00  (18.40)
Mean Change from Baseline 5.25  (4.85) 5.92  (5.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anodal tDCS, Sham tDCS
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Statistical analysis for mean change from baseline in naming accuracy in the anodal vs. sham tDCS conditions Null hypothesis is that there was no difference in mean change of naming accuracy between anodal and sham tDCS conditions. A significance level of 0.05 was used (two-sided).
Statistical Test of Hypothesis P-Value 0.694
Comments The wilcoxon sign-ranked test was performed for this crossover design study in which subjects underwent measures across 2 study conditions (paired samples: mean change in anodal vs. sham condition). A significance level of 0.05 was used (two-sided).
Method wilcoxon sign-ranked test
Comments Western Aphasia Battery used as a screening tool on admission only, to characterize level of severity. It was NOT an outcome measure.
Time Frame Two weeks for each intervention
Adverse Event Reporting Description Safety population included all participants who received at least one dose of intervention.
 
Arm/Group Title Anodal tDCS Sham tDCS
Hide Arm/Group Description Participants who received anodal tDCS + computerized picture-naming therapy, and were followed for 2 weeks. Participants who received sham tDCS + computerized picture-naming therapy, and were followed for 2 weeks.
All-Cause Mortality
Anodal tDCS Sham tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Anodal tDCS Sham tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anodal tDCS Sham tDCS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
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
Name/Title: Johanna Chang, Senior Research Coordinator
Organization: Northwell Health
Phone: (516)562-3646
Responsible Party: Bruce Volpe, Northwell Health
ClinicalTrials.gov Identifier: NCT02249819     History of Changes
Other Study ID Numbers: 14-416
First Submitted: September 23, 2014
First Posted: September 26, 2014
Results First Submitted: February 1, 2018
Results First Posted: April 6, 2018
Last Update Posted: February 26, 2019