Trial Outcomes & Findings for HDtDCS in Logopenic Variant PPA: Effects on Language and Neural Mechanisms (NCT NCT03805659)
NCT ID: NCT03805659
Last Updated: 2024-06-11
Results Overview
Language performance as assessed at baseline and post-stimulation procedure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Language performance was assessed before and after 2-week intervention and during washout periods
Results posted on
2024-06-11
Participant Flow
6 patients were screened for eligibility between 02/24/2020 and 05/18/2022.
5 of 6 subjects were randomized. 1 subject withdrew themselves prior to starting baseline procedures.
Participant milestones
| Measure |
HD-tDCS, Then Sham
Subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). After a washout period of 16 weeks, subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
HD-tDCS: High-Dose transcranial Direct Current Stimulation
Sham: Sham sessions (no electric current)
|
Sham, Then HD-tDCS
Subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). After a washout period of 16 weeks, subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
HD-tDCS: High-Dose transcranial Direct Current Stimulation
Sham: Sham sessions (no electric current)
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
First Intervention (2 Weeks)
|
2
|
2
|
|
Overall Study
Assessment 1 Cognitive Testing (8 Weeks After First Intervention)
|
2
|
2
|
|
Overall Study
Washout (16 Weeks)
|
2
|
2
|
|
Overall Study
Second Intervention (2 Weeks)
|
2
|
2
|
|
Overall Study
Assessment 2 Cognitive Testing (8 Weeks After Intervention)
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
HD-tDCS, Then Sham
Subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). After a washout period of 16 weeks, subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
HD-tDCS: High-Dose transcranial Direct Current Stimulation
Sham: Sham sessions (no electric current)
|
Sham, Then HD-tDCS
Subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). After a washout period of 16 weeks, subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
HD-tDCS: High-Dose transcranial Direct Current Stimulation
Sham: Sham sessions (no electric current)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
HDtDCS in Logopenic Variant PPA: Effects on Language and Neural Mechanisms
Baseline characteristics by cohort
| Measure |
HD-tDCS, Then Sham
n=2 Participants
Subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). After a washout period of 16 weeks, subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
HD-tDCS: High-Dose transcranial Direct Current Stimulation
Sham: Sham sessions (no electric current)
|
Sham, Then HD-tDCS
n=3 Participants
Subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday). After a washout period of 16 weeks, subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
HD-tDCS: High-Dose transcranial Direct Current Stimulation
Sham: Sham sessions (no electric current)
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 8.49 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 3.06 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 5.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Language performance was assessed before and after 2-week intervention and during washout periodsPopulation: No data were collected for this outcome measure.
Language performance as assessed at baseline and post-stimulation procedure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Language network resting state changes were assessed before and after 2-week intervention and during washout periodsPopulation: No data were collected for this outcome measure.
Language network resting state changes after stimulation procedure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Resting-state neuronal frequencies and synchronizations changes were assessed before and after 2-week intervention and during washout periodsPopulation: No data were collected for this outcome measure.
Resting-state neuronal frequencies and synchronizations changes after stimulation procedure
Outcome measures
Outcome data not reported
Adverse Events
HD-tDCS
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HD-tDCS
n=4 participants at risk
Subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
Adverse events reported in this group include relevant medical occurrences from the 10 sessions of HD-tDCS through post-intervention follow-up.
HD-tDCS: High-Dose transcranial Direct Current Stimulation
|
Sham
n=4 participants at risk
Subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
Adverse events reported in this group include relevant medical occurrences from the 10 sessions of sham through post-intervention follow-up.
Sham: Sham sessions (no electric current)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
25.0%
1/4 • Number of events 1 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
0.00%
0/4 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
Other adverse events
| Measure |
HD-tDCS
n=4 participants at risk
Subjects receive High Dose transcranial Direct Current Stimulation (HD-tDCS) lasting 20 minutes at an electric current intensity of up to 2mA in the left posterior temporo-parietal cortex (TPC). Stimulation sessions are delivered once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
Adverse events reported in this group include relevant medical occurrences from the 10 sessions of HD-tDCS through post-intervention follow-up.
HD-tDCS: High-Dose transcranial Direct Current Stimulation
|
Sham
n=4 participants at risk
Subjects receive Sham sessions (no electric current) once a day (QD) for a total of 10 sessions over 2 weeks (Monday-Friday).
Adverse events reported in this group include relevant medical occurrences from the 10 sessions of sham through post-intervention follow-up.
Sham: Sham sessions (no electric current)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bleeding at electrode site
|
0.00%
0/4 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
25.0%
1/4 • Number of events 1 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
|
Injury, poisoning and procedural complications
Erythema at collar bone post MEG
|
0.00%
0/4 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
25.0%
1/4 • Number of events 1 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
|
General disorders
Headaches
|
0.00%
0/4 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
25.0%
1/4 • Number of events 1 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
|
Renal and urinary disorders
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
0.00%
0/4 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
|
Social circumstances
Fall
|
25.0%
1/4 • Number of events 1 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
0.00%
0/4 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
|
Psychiatric disorders
Increased panic attacks
|
25.0%
1/4 • Number of events 1 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
0.00%
0/4 • Informed consent through study completion, approximately 28 weeks.
Safety Population included all subjects who received at least one intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place