Trial Outcomes & Findings for Modulating Default Mode Network Function: A Transcranial Direct Current Stimulation (TDCS) Pilot Study (NCT NCT04598152)

Last Updated: 2022-01-04

Results Overview

The investigators will determine the effects of TDCS on BOLD response in the precuneus/posterior cingulate gyrus. The BOLD signal is a measure of regional blood flow in the brain and is used as a proxy for neural activity in specific brain regions. Values below represent pre-post change in BOLD response to the emotion regulation task that participants complete during fMRI scanning. We hypothesize that tDCS applied to the target used in this study will decrease BOLD signal (lower values) during critical components of this task, normalizing function in this region.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

1 week (between baseline and repeat scanning)

Results posted on

2022-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	Sham Transcranial Direct Current Stimulation (tDCS) During fMRI Followed by Active tDCS During fMRI Each subject will first undergo sham transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. One week later, they will receive active tDCS during the task in the scanner. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously.	ActiveTranscranial Direct Current Stimulation (tDCS) During fMRI Followed by Sham tDCS During fMRI Each subject will first undergo active transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. One week later, they will receive sham tDCS during the task in the scanner.
Overall Study STARTED	3	1
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sham Transcranial Direct Current Stimulation (tDCS) During fMRI Followed by Active tDCS During fMRI Each subject will first undergo sham transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. One week later, they will receive active tDCS during the task in the scanner. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously.	ActiveTranscranial Direct Current Stimulation (tDCS) During fMRI Followed by Sham tDCS During fMRI Each subject will first undergo active transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. One week later, they will receive sham tDCS during the task in the scanner.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Modulating Default Mode Network Function: A Transcranial Direct Current Stimulation (TDCS) Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Both Arms Reported Together. n=4 Participants Because only 1 participant entered in the real followed by sham condition, we report baseline variables combined across the arms. All 4 participants received active tDCS. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23.5 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants
Quick Inventory Depressive Symptoms	11.0 units on a scale STANDARD_DEVIATION 3.6 • n=5 Participants
PROMIS Anxiety Short Form	23.5 units on a scale STANDARD_DEVIATION .6 • n=5 Participants

PRIMARY outcome

Timeframe: 1 week (between baseline and repeat scanning)

Population: Because no subjects completed the Active followed by Sham tDCS arm, results are reported for the 3 individuals who completed the Sham followed by Active tDCS arm only.

Outcome measures

Outcome measures
Measure	Active vs Sham Transcranial Direct Current Stimulation During fMRI n=3 Participants Each subject will undergo transcranial direct current stimulation twice while completing a task in the functional magnetic resonance imaging scanner. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously. This is a within subjects design. Each participant received both active and sham treatment in a randomized crossover design. The outcome of interest is the within-person difference in BOLD response between the active and sham tDCS administrations. As such, only one "arm" is reported.
Blood Oxygen Level Dependent (BOLD) Response in the Precuneus During an Emotion Regulation Task Completed During fMRI Scanning.	-.09 arbitrary units Standard Deviation .36

SECONDARY outcome

Timeframe: 30 minutes to 1 hour (the period during which the tDCS device was worn) on each of two scan days

Population: Because no subjects completed the Active followed by Sham tDCS arm, results are reported for the 3 individuals who completed the Sham followed by Active tDCS arm only.

Potential side effects (e.g., headaches, dizziness, uncomfortable sensations, etc...) will be assessed after each tDCS and sham-tDCS administration. Side effects were assessed using a standardized form. Count below represents the number of participants who reported a mild or moderate side effect during active tDCS but not sham tDCS.

Outcome measures

Outcome measures
Measure	Active vs Sham Transcranial Direct Current Stimulation During fMRI n=3 Participants Each subject will undergo transcranial direct current stimulation twice while completing a task in the functional magnetic resonance imaging scanner. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously. This is a within subjects design. Each participant received both active and sham treatment in a randomized crossover design. The outcome of interest is the within-person difference in BOLD response between the active and sham tDCS administrations. As such, only one "arm" is reported.
The Percentage of Patients Who Reported a Side Effect in the Active tDCS Condition But Not the Sham tDCS Condition	3 Participants

Adverse Events

Active Transcranial Direct Current Stimulation During fMRI

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham Transcranial Direct Current Stimulation During fMRI

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active Transcranial Direct Current Stimulation During fMRI n=4 participants at risk Each subject will undergo both active and sham transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously. This is a within subjects design. Each participant received both active and sham tDCS in a randomized crossover design. The critical determinant of adverse events due to tDCS is the number reported during the active tDCS condition compared to those reported during the sham tDCS condition. As such, only one "arm" is reported, and it represents the number of events reported during active tDCS that were not reported by the same individual(s) during sham tDCS. 4 cases are reported (rather than 3) out of abundance of caution as one individual received only active tDCS and was lost to follow-up and so could not contribute the necessary data for the primary or secondary outcomes.	Sham Transcranial Direct Current Stimulation During fMRI n=3 participants at risk Each subject will undergo both active and sham transcranial direct current stimulation while completing a task in the functional magnetic resonance imaging scanner. TDCS - transcranial direct current stimulation: TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously. This is a within subjects design. Each participant received both active and sham tDCS in a randomized crossover design. The critical determinant of adverse events due to tDCS is the number reported during the active tDCS condition compared to those reported during the sham tDCS condition. As such, only one "arm" is reported, and it represents the number of events reported during active tDCS that were not reported by the same individual(s) during sham tDCS. 4 cases are reported (rather than 3) out of abundance of caution as one individual received only active tDCS and was lost to follow-up and so could not contribute the necessary data for the primary or secondary outcomes.
Nervous system disorders headache	75.0% 3/4 • Number of events 3 • 1 day (the day of the scan).	0.00% 0/3 • 1 day (the day of the scan).
Nervous system disorders Scalp burning/itching/tingling sensation	100.0% 4/4 • Number of events 4 • 1 day (the day of the scan).	100.0% 3/3 • Number of events 3 • 1 day (the day of the scan).
Nervous system disorders Sleepiness/dizziness	75.0% 3/4 • Number of events 3 • 1 day (the day of the scan).	33.3% 1/3 • Number of events 1 • 1 day (the day of the scan).
Nervous system disorders tension/anxiety/disorientation	50.0% 2/4 • Number of events 2 • 1 day (the day of the scan).	0.00% 0/3 • 1 day (the day of the scan).
Nervous system disorders Mood change or difficulty concentrating	0.00% 0/4 • 1 day (the day of the scan).	66.7% 2/3 • Number of events 2 • 1 day (the day of the scan).

Additional Information

Jay Fournier, PhD

The Ohio State University College of Medicine

Phone: 614-293-9600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place