Cognitive ChangePCN1NCT03034954

Patient Centered-Rehabilitation ver111090.1

A study testing Active HD-tDCS in people with Cognitive Change, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of electricity to modulate brain functioning, can improve cognitive abilities. Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Cognitive Change
What is being tested?: Active HD-tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Oct 2016to Oct 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Individuals with intact cognitive functioning.
Participants will be age 50 or older.

Who cannot join

Individuals with a documented history of cognitive impairment.
A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders)
Sensory or motor impairments that limit the ability to take part in the study
A significant history or current use of alcohol or drug abuse/dependence
Those who are currently pregnant (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)
Participants with an Mini Mental State Examination score <24 at screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan - Department of Psychiatry
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Effects of 3mA HD-tDCS on Associative and Working Memory in Cognitively Intact Older Adults

Read the detailed description

The primary objective is to investigate the cognitive effects of high definition anodal tDCS (HD-tDCS; anode at center electrode) at 3 mA (for 20 minutes) on learning, memory, and working memory. Participants will be randomized to active or sham stimulation and will complete a series of cognitive tests both during and after stimulation.

Tolerability and blinding will also be evaluated using standard side effect questionnaires.

Conditions: Cognitive Change
Being tested: Active HD-tDCS, Sham HD-tDCS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active HD-tDCSDevice
Also called HD-tDCS
Participants will receive active HD-tDCS at 3mA for 20 minutes
Sham HD-tDCSDevice
Participants will receive sham HD-tDCS

Study groups in NCT03034954
Study group	Role	What they receive
Active HD-tDCS	Active comparator	Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session. Receives: Device: Active HD-tDCS
Sham HD-tDCS	Sham comparator	Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session. Receives: Device: Sham HD-tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

Object Location Touchscreen Task (Version C) Free Recall Total Error
The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.
Measured: 15 minutes after encoding
Object Location Touchscreen Task (Version C) Free Recall Average Error
The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.
Measured: 15 minutes after encoding
Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond
The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Measured: 15 minutes after encoding
Object Location Touchscreen Task (Version C) Cued Recall Total Error
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.
Measured: 15 minutes after encoding
Object Location Touchscreen Task (Version C) Cued Recall Average Error
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.
Measured: 15 minutes after encoding
Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Measured: 15 minutes after encoding
Object Location Touchscreen Task (Version C) Recognition Total Correct
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.
Measured: 15 minutes after encoding
Object Location Touchscreen Task (Version C) Recognition Average Time to Respond
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Measured: 15 minutes after encoding
Performance (d') on a Simple Attention (0-back) Test
The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
Measured: 30 minutes post-stimulation
Performance (d') on a Working Memory (2-back) Test
The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
Measured: 30 minutes post-stimulation
Performance (d') on a Working Memory (Semantic 2-back) Test
The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
Measured: 30 minutes post-stimulation
Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')
The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.
Measured: 30 minutes post-stimulation
Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')
The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.
Measured: 30 minutes post-stimulation

Secondary outcomes (11)

Blinding in Total Sample
Participants were asked to estimate which group they were in (i.e., active or sham).
Measured: ~1 minute post stimulation
Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Measured: ~1 minute post stimulation
Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Measured: ~1 minute post stimulation
Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Measured: ~1 minute post stimulation
Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Measured: ~1 minute post stimulation
Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Measured: ~1 minute post stimulation
Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Measured: ~1 minute post stimulation
Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Measured: ~1 minute post stimulation
Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Measured: ~1 minute post stimulation
Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Measured: ~1 minute post stimulation
Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
Measured: ~1 minute post stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Oct 2017

First posted27 Jan 2017 (estimated)
Study startOct 2016
Primary completionJun 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cognitive ChangeStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03034954
Sponsor's protocol ID: HUM00111090.1 PCN
Acronym: PCN1
Status last verified: Jul 2018
First submitted: 24 Oct 2016
Last updated: 16 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
PubMed 21320389

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cognitive Change trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of 3mA HD-tDCS on Associative and Working Memory in Cognitively Intact Older Adults
ClinicalTrials.gov ID: NCT03034954
Acronym / sponsor ID: PCN1 / HUM00111090.1 PCN
Conditions: Cognitive Change
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: Oct 2016 (actual)
Primary completion: Jun 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 27 Jan 2017 (estimated)
Results: Posted 16 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Tolerability and blinding will also be evaluated using standard side effect questionnaires.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Active HD-tDCS	Active comparator	Device: Active HD-tDCSParticipants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session.
Sham HD-tDCS	Sham comparator	Device: Sham HD-tDCSParticipants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Individuals with intact cognitive functioning.
Participants will be age 50 or older.

Key exclusion criteria (6 listed)

Individuals with a documented history of cognitive impairment.
A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders)
Sensory or motor impairments that limit the ability to take part in the study
A significant history or current use of alcohol or drug abuse/dependence
Those who are currently pregnant (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active HD-tDCSAlso: HD-tDCSParticipants will receive active HD-tDCS at 3mA for 20 minutes	Device	Active HD-tDCS
Sham HD-tDCSParticipants will receive sham HD-tDCS	Device	Sham HD-tDCS

Primary outcome

Object Location Touchscreen Task (Version C) Free Recall Total Error
Time frame: 15 minutes after encoding
The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.
Object Location Touchscreen Task (Version C) Free Recall Average Error
Time frame: 15 minutes after encoding
The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.
Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond
Time frame: 15 minutes after encoding
The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Object Location Touchscreen Task (Version C) Cued Recall Total Error
Time frame: 15 minutes after encoding
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.
Object Location Touchscreen Task (Version C) Cued Recall Average Error
Time frame: 15 minutes after encoding
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.
Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond
Time frame: 15 minutes after encoding
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Object Location Touchscreen Task (Version C) Recognition Total Correct
Time frame: 15 minutes after encoding
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.
Object Location Touchscreen Task (Version C) Recognition Average Time to Respond
Time frame: 15 minutes after encoding
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.
Performance (d') on a Simple Attention (0-back) Test
Time frame: 30 minutes post-stimulation
The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
Performance (d') on a Working Memory (2-back) Test
Time frame: 30 minutes post-stimulation
The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
Performance (d') on a Working Memory (Semantic 2-back) Test
Time frame: 30 minutes post-stimulation
The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.
Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')
Time frame: 30 minutes post-stimulation
The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.
Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')
Time frame: 30 minutes post-stimulation
The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.

11 secondary outcomes

Blinding in Total Sample
Time frame: ~1 minute post stimulation
Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session
Time frame: ~1 minute post stimulation
Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session
Time frame: ~1 minute post stimulation
Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session
Time frame: ~1 minute post stimulation
Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session
Time frame: ~1 minute post stimulation
Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session
Time frame: ~1 minute post stimulation
Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session
Time frame: ~1 minute post stimulation
Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session
Time frame: ~1 minute post stimulation
Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session
Time frame: ~1 minute post stimulation
Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session
Time frame: ~1 minute post stimulation
Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session
Time frame: ~1 minute post stimulation

Results and safety

Results posted to the registry on 16 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active HD-tDCS	21	20
Sham HD-tDCS	21	21

Primary outcome: Object Location Touchscreen Task (Version C) Free Recall Total Error

Time frame: 15 minutes after encoding. Mean (Standard Deviation). Unit: centimeters

Measure	Active HD-tDCS n = 19	Sham HD-tDCS n = 20
Value	121.498 (26.366)	99.77 (27.845)

Active HD-tDCS vs Sham HD-tDCS: p = .300, Repeated Measures ANOVA

Population analysed: Missing data for one participant

Primary outcome: Object Location Touchscreen Task (Version C) Free Recall Average Error

Time frame: 15 minutes after encoding. Mean (Standard Deviation). Unit: centimeters

Measure	Active HD-tDCS n = 19	Sham HD-tDCS n = 20
Value	8.099 (1.757)	6.652 (1.856)

Population analysed: Missing data for one participant

Primary outcome: Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond

Time frame: 15 minutes after encoding. Mean (Standard Deviation). Unit: milliseconds

Measure	Active HD-tDCS n = 19	Sham HD-tDCS n = 20
Value	3419.878 (1690.354)	3029.648 (1572.416)

Active HD-tDCS vs Sham HD-tDCS: p = .044, Repeated Measures ANOVA
Active HD-tDCS vs Sham HD-tDCS: p = .006, Repeated Measures ANOVA

Population analysed: Missing data for one participant

Primary outcome: Object Location Touchscreen Task (Version C) Cued Recall Total Error

Time frame: 15 minutes after encoding. Mean (Standard Deviation). Unit: centimeters

Measure	Active HD-tDCS n = 19	Sham HD-tDCS n = 20
Value	66.806 (29.303)	43.775 (29.32)

Population analysed: Missing data for one participant

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected for the duration of participation (i.e., approximately 2-3 hours). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active HD-tDCS	0 of 19 (0%)	16 of 19 (84.2%)	0 of 19
Sham HD-tDCS	0 of 21 (0%)	19 of 21 (90.5%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21320389Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benjamin M Hampstead, PhD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active HD-tDCS in people with Cognitive Change, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Object Location Touchscreen Task (Version C) Free Recall Total Error (time frame: 15 minutes after encoding). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03034954, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.