Cognitive ChangeNCT03807934
Cerebral Excitability and Cognitive Performance
A study testing Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems in people with Cognitive Change, run by Tufts University at 1 site in United States.
Trial summary
This study investigates the perceptual and cognitive influences of low-intensity electrical brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham) conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2013to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between ages of 18-65.
Who cannot join
- History of adverse reaction to tDCS (trans-cranial direct current stimulation).
- History of seizure activity.
- History of head injury (including neurosurgery).
- History of illness causing brain injury.
- History of other brain-related condition (such as traumatic brain injury).
- History of diagnosis with a neurological or psychiatric disorder.
- History of metal in head (outside of mouth), such as shrapnel, surgical clips, or fragments from welding or metalwork.
- History of sensitive scalp.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the perceptual and cognitive influences of low-intensity electrical brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham) conditions.
- Conditions
- Cognitive Change
- Being tested
- Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems
- Keywords
- transcranial direct current stimulation, cognitive psychology, noninvasive brain stimulation, electrical brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systemsOther
Active (at or below 2mA) versus sham (at or below 0.5mA) stimulation targeting brain regions engaged during verbal and/or spatial perceptual and cognitive processing. Brain stimulation devices are not currently regulated by the United States Food and Drug Administration. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.
| Study group | Role | What they receive |
|---|---|---|
| Active High-Definition Stimulation | Experimental | Active high-definition stimulation of targeted brain regions involved in perception and cognition. Receives: Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems |
| Sham High-Definition Stimulation | Sham comparator | Sham high-definition stimulation of targeted brain regions involved in perception and cognition. Receives: Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual perceptual performance
Ability to accurately and efficiently perceive perceptual information, including threat detection, local contrast gradient detection, face memory, and intent appraisal. All are computerized tasks.
Measured: 36 weeks
Verbal cognitive performance
Ability to accurately and efficiently process verbal information, including verbal cued free association tasks, verbal long-term memory, and language comprehension. All are computerized tasks.
Measured: 36 weeks
Spatial cognitive performance
Ability to accurately and efficiently process spatial information, including map learning, virtual urban navigation, and mental rotation. All are computerized tasks.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start15 Apr 2013
- Primary completion14 Apr 2023 (estimated)
- Study completion14 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated-measures crossover design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tad Brunye, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807934
- Sponsor's protocol ID
- 1303018
- Status last verified
- Apr 2021
- First submitted
- 11 Jan 2019
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brunye TT, Hussey EK, Fontes EB, Ward N. Modulating Applied Task Performance via Transcranial Electrical Stimulation. Front Hum Neurosci. 2019 Apr 30;13:140. doi: 10.3389/fnhum.2019.00140. eCollection 2019.
PubMed 31114491Brunye TT, Smith AM, Horner CB, Thomas AK. Verbal long-term memory is enhanced by retrieval practice but impaired by prefrontal direct current stimulation. Brain Cogn. 2018 Dec;128:80-88. doi: 10.1016/j.bandc.2018.09.008. Epub 2018 Nov 8.
PubMed 30414699Brunye TT. Modulating Spatial Processes and Navigation via Transcranial Electrical Stimulation: A Mini Review. Front Hum Neurosci. 2018 Jan 9;11:649. doi: 10.3389/fnhum.2017.00649. eCollection 2017.
PubMed 29375346Brunye TT, Moran JM, Cantelon J, Holmes A, Eddy MD, Mahoney CR, Taylor HA. Increasing breadth of semantic associations with left frontopolar direct current brain stimulation: a role for individual differences. Neuroreport. 2015 Mar 25;26(5):296-301. doi: 10.1097/WNR.0000000000000348.
PubMed 25714417Brunye TT, Holmes A, Cantelon J, Eddy MD, Gardony AL, Mahoney CR, Taylor HA. Direct current brain stimulation enhances navigation efficiency in individuals with low spatial sense of direction. Neuroreport. 2014 Oct 22;25(15):1175-9. doi: 10.1097/WNR.0000000000000214.
PubMed 25144391
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Excitability and Cognitive Performance
- ClinicalTrials.gov ID
- NCT03807934
- Acronym / sponsor ID
- 1303018
- Conditions
- Cognitive Change
- Keywords
- transcranial direct current stimulation, cognitive psychology, noninvasive brain stimulation, electrical brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 15 Apr 2013 (actual)
- Primary completion
- 14 Apr 2023 (estimated)
- Study completion
- 14 Apr 2023 (estimated)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the perceptual and cognitive influences of low-intensity electrical brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham) conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Repeated-measures crossover design.
| Arm | Type | Receives |
|---|---|---|
| Active High-Definition Stimulation | Experimental | Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systemsActive high-definition stimulation of targeted brain regions involved in perception and cognition. |
| Sham High-Definition Stimulation | Sham comparator | Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systemsSham high-definition stimulation of targeted brain regions involved in perception and cognition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Between ages of 18-65.
Key exclusion criteria (8 listed)
- History of adverse reaction to tDCS (trans-cranial direct current stimulation).
- History of seizure activity.
- History of head injury (including neurosurgery).
- History of illness causing brain injury.
- History of other brain-related condition (such as traumatic brain injury).
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 |
|---|---|---|
| Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systemsActive (at or below 2mA) versus sham (at or below 0.5mA) stimulation targeting brain regions engaged during verbal and/or spatial perceptual and cognitive processing. Brain stimulation devices are not currently regulated by the United States Food and Drug Administration. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure. | Other | Active High-Definition Stimulation, Sham High-Definition Stimulation |
Primary outcome
Visual perceptual performance
Time frame: 36 weeks
Ability to accurately and efficiently perceive perceptual information, including threat detection, local contrast gradient detection, face memory, and intent appraisal. All are computerized tasks.
Verbal cognitive performance
Time frame: 36 weeks
Ability to accurately and efficiently process verbal information, including verbal cued free association tasks, verbal long-term memory, and language comprehension. All are computerized tasks.
Spatial cognitive performance
Time frame: 72 weeks
Ability to accurately and efficiently process spatial information, including map learning, virtual urban navigation, and mental rotation. All are computerized tasks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Results publication: PubMed 31114491Brunye TT, Hussey EK, Fontes EB, Ward N. Modulating Applied Task Performance via Transcranial Electrical Stimulation. Front Hum Neurosci. 2019 Apr 30;13:140. doi: 10.3389/fnhum.2019.00140. eCollection 2019.
- Results publication: PubMed 30414699Brunye TT, Smith AM, Horner CB, Thomas AK. Verbal long-term memory is enhanced by retrieval practice but impaired by prefrontal direct current stimulation. Brain Cogn. 2018 Dec;128:80-88. doi: 10.1016/j.bandc.2018.09.008. Epub 2018 Nov 8.
- Results publication: PubMed 29375346Brunye TT. Modulating Spatial Processes and Navigation via Transcranial Electrical Stimulation: A Mini Review. Front Hum Neurosci. 2018 Jan 9;11:649. doi: 10.3389/fnhum.2017.00649. eCollection 2017.
- Results publication: PubMed 25714417Brunye TT, Moran JM, Cantelon J, Holmes A, Eddy MD, Mahoney CR, Taylor HA. Increasing breadth of semantic associations with left frontopolar direct current brain stimulation: a role for individual differences. Neuroreport. 2015 Mar 25;26(5):296-301. doi: 10.1097/WNR.0000000000000348.
- Results publication: PubMed 25144391Brunye TT, Holmes A, Cantelon J, Eddy MD, Gardony AL, Mahoney CR, Taylor HA. Direct current brain stimulation enhances navigation efficiency in individuals with low spatial sense of direction. Neuroreport. 2014 Oct 22;25(15):1175-9. doi: 10.1097/WNR.0000000000000214.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems in people with Cognitive Change, run by Tufts University 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Apr 2021. 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?
Results are not available in the source record.
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?
Visual perceptual performance (time frame: 36 weeks). The study lists 3 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 NCT03807934, which also lists 5 linked publications.
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 5 Apr 2021.