Trial Outcomes & Findings for A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression (NCT NCT05188248)
NCT ID: NCT05188248
Last Updated: 2024-01-10
Results Overview
Measured by the Beck Depression Inventory (BDI-II) which is a brief, criteria-referenced assessment for measuring depression severity. The BDI-II consists of 21 items to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The items are scored as 0, 1, 2, or 3. The score range is 0-63. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.
COMPLETED
NA
21 participants
Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
2024-01-10
Participant Flow
Participant milestones
| Measure |
Female Participants With Depression
Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.
Transcranial direct current stimulation (tDCS): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
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Overall Study
STARTED
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21
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Overall Study
COMPLETED
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21
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression
Baseline characteristics by cohort
| Measure |
Female Participants With Depression
n=21 Participants
Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.
Transcranial direct current stimulation (tDCS): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
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Age, Continuous
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25 years
STANDARD_DEVIATION 6.53 • n=5 Participants
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Sex: Female, Male
Female
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21 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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20 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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5 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=5 Participants
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Race (NIH/OMB)
White
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13 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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21 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)Measured by the Beck Depression Inventory (BDI-II) which is a brief, criteria-referenced assessment for measuring depression severity. The BDI-II consists of 21 items to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The items are scored as 0, 1, 2, or 3. The score range is 0-63. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.
Outcome measures
| Measure |
Female Participants With Depression
n=21 Participants
Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.
Transcranial direct current stimulation (tDCS): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
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Beck Depression Inventory (BDI-II) Score
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21.29 score on a scale
Standard Deviation 5.29
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PRIMARY outcome
Timeframe: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking "How anxious are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety.
Outcome measures
| Measure |
Female Participants With Depression
n=21 Participants
Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.
Transcranial direct current stimulation (tDCS): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
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Analog Mood Scale (AMS) Anxiety Score
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7.95 score on a scale
Standard Deviation 5.75
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PRIMARY outcome
Timeframe: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking "How sad are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness.
Outcome measures
| Measure |
Female Participants With Depression
n=21 Participants
Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.
Transcranial direct current stimulation (tDCS): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
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Analog Mood Scale (AMS) Sad Score
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7.19 score on a scale
Standard Deviation 5.1
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PRIMARY outcome
Timeframe: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)Analog Mood Scale (AMS) Happy is a brief measure of positive and negative mood asking "How happy are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of happiness.
Outcome measures
| Measure |
Female Participants With Depression
n=21 Participants
Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.
Transcranial direct current stimulation (tDCS): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
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Analog Mood Scale (AMS) Happy Score
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11.67 score on a scale
Standard Deviation 6.16
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PRIMARY outcome
Timeframe: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking "How anxious are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety. The AMS Anxiety will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Anxiety scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less anxiety post-tDCS administration. A negative value indicates increased anxiety post-tDCS administration.
Outcome measures
| Measure |
Female Participants With Depression
n=21 Participants
Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.
Transcranial direct current stimulation (tDCS): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
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Change in Analog Mood Scale (AMS) Anxiety Score
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2.76 score on a scale
Standard Deviation 2.8
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PRIMARY outcome
Timeframe: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking "How sad are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness. The AMS Sad will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Sad scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less sadness post-tDCS administration. A negative value indicates increased sadness post-tDCS administration.
Outcome measures
| Measure |
Female Participants With Depression
n=21 Participants
Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.
Transcranial direct current stimulation (tDCS): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
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Change in Analog Mood Scale (AMS) Sad Score
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2.62 score on a scale
Standard Deviation 2.7
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PRIMARY outcome
Timeframe: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)The Visual Search task will be administered to further assess attention bias, particularly examining the interference and facilitation effects in attention using emotional stimuli. The task uses emotional faces or words as stimuli, where the participant is instructed to search for the face that does not fit into the search set with respect to gender, where the target and distractors are expressing different or same emotions. This study will use this task as an outcome measure of Attention Bias. For this task, the change in mean response time (the time between display onset and button press) to the target stimulus is measured as the main outcome variable.
Outcome measures
| Measure |
Female Participants With Depression
n=21 Participants
Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.
Transcranial direct current stimulation (tDCS): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
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Change in Normalized Response Time
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-0.39 milliseconds
Standard Deviation 0.6
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Adverse Events
Female Participants With Depression
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place