SleepNCT02596568
The Effect of tDCS Applied During Sleep on Memory Consolidation
A study testing transcranial direct current stimulation (tDCS) in people with Sleep, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will attempt to use a type of non-invasive brain stimulation technology during sleep to improve measures of sleep quality and memory in young healthy students and older adults. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Nov 2013
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students
- Adults aged 60 or greater.
Who cannot join
- If they are taking any prescription or over the counter medications.
- If they have any currently active neurologic, psychiatric, hormonal, metabolic, circulatory, or sleep disturbances. -They must specifically not have a history of seizures, closed head injuries with loss of consciousness for greater than 5 minutes, any known brain tumors or lesions, metal implants or implanted devices above the neck, a history of eczema, or other sensitive conditions, or an allergy to latex.
- They must not smoke cigarettes, use illicit drugs, or meet criteria for alcohol abuse or dependence in their lifetime defined by SCID criteria.
- They must be free of alcohol for at least 48 hours prior to each night of the study
- They must not consume more than the equivalent of 500mg of caffeine daily.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: The Use of Transcranial Direct Current Stimulation During Slow Wave Sleep in Healthy Students and Older Adults
This study will attempt to use a type of non-invasive brain stimulation technology during sleep to improve measures of sleep quality and memory in young healthy students and older adults. The type of brain stimulation is called transcranial direct current stimulation (tDCS), which uses small currents of electricity to increase or decrease the activity of specific areas of the brain.
Read the detailed description
Transcranial direct current stimulation (tDCS) is a safe, non-invasive, and inexpensive brain stimulation modality that has been shown to have the ability to modulate both cortical and deep brain structure activity. This technique has undergone a significant amount of investigation in varied neuropsychiatric populations and interest in this technique has increased dramatically as of late.
Some researchers have studied the effects of this modality on sleep as well as memory with promising results. One such study demonstrated that by using bilateral tDCS with a pattern of stimulation in the delta frequency range (0-3 Hz) delivered during slow wave sleep, that it is possible to increase delta power during slow wave sleep, as well as improve sleep efficiency. In addition to showing that it is possible to enhance slow waves, it was also demonstrated that this increase was associated with an improvement of a measure of declarative memory consolidation (one of the theorized functions of slow wave sleep). Enhancing memory function in a normal healthy group raises the possibility that it would also be possible to enhance memory in clinical populations who would benefit from such an intervention.
The investigators propose to test this intervention for replication in a similar cohort.
- Conditions
- Sleep
- Being tested
- transcranial direct current stimulation (tDCS), Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
tDCS is a type of brain stimulation that uses low current applied directly over the scalp to increase, or decrease cortical activity under the stimulating electrodes. tDCS applied bi-frontally using Chattanooga Ionto™ Iontophoresis System - Phoresor. A square wave will be delivered at 0.75 Hz for five blocks of five minutes each with one minute inter-train interval. Stimulation will be applied following 8 epochs of consecutive stage 2 or deeper sleep.
ShamOther
tDCS device connected and tested, but not turned on during the night. This has been found to be an effective sham in other studies using this technique.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS stimulation | Experimental | Anodal tDCS will be applied bi-frontally using Chattanooga Ionto™ Iontophoresis System - Phoresor. A square wave will be delivered at 0.75 Hz for five blocks of five minutes each with one minute inter-train interval. Stimulation will be applied following 8 epochs of consecutive stage 2 or deeper sleep. Receives: Device: transcranial direct current stimulation (tDCS) |
| Sham tDCS stimulation | Sham comparator | tDCS electrodes will be applied bi-frontally using Chattanooga Ionto™ Iontophoresis System - Phoresor, however stimulation will never be turned on. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Declarative memory assessed by paired word association test
Prior to and directly after a night of sleep we will assess declarative memory using a paired word association tests. In the pre-sleep assessment there will be a learning phase where the word list will be presented serially, until 60% of the words are retained. In the post sleep assessment the word list will be given again once. The outcome measure is the change in words retained between pre and post sleep assessments. Subsequently the followup interval is approximately 8-9 hours with baseline before bedtime, and follow up assessment once the patient is awoken.
Measured: Pre sleep/intervention, and post sleep/intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startJan 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Sahlem, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596568
- Sponsor's protocol ID
- Pro00020393
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2014
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Transcranial Direct Current Stimulation During Slow Wave Sleep in Healthy Students and Older Adults
- ClinicalTrials.gov ID
- NCT02596568
- Acronym / sponsor ID
- Pro00020393
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Nov 2015 (estimated)
- 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 will attempt to use a type of non-invasive brain stimulation technology during sleep to improve measures of sleep quality and memory in young healthy students and older adults. The type of brain stimulation is called transcranial direct current stimulation (tDCS), which uses small currents of electricity to increase or decrease the activity of specific areas of the brain.
Detailed description
Transcranial direct current stimulation (tDCS) is a safe, non-invasive, and inexpensive brain stimulation modality that has been shown to have the ability to modulate both cortical and deep brain structure activity. This technique has undergone a significant amount of investigation in varied neuropsychiatric populations and interest in this technique has increased dramatically as of late.
Some researchers have studied the effects of this modality on sleep as well as memory with promising results. One such study demonstrated that by using bilateral tDCS with a pattern of stimulation in the delta frequency range (0-3 Hz) delivered during slow wave sleep, that it is possible to increase delta power during slow wave sleep, as well as improve sleep efficiency. In addition to showing that it is possible to enhance slow waves, it was also demonstrated that this increase was associated with an improvement of a measure of declarative memory consolidation (one of the theorized functions of slow wave sleep). Enhancing memory function in a normal healthy group raises the possibility that it would also be possible to enhance memory in clinical populations who would benefit from such an intervention.
The investigators propose to test this intervention for replication in a similar cohort.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS stimulation | Experimental | Device: transcranial direct current stimulation (tDCS)Anodal tDCS will be applied bi-frontally using Chattanooga Ionto™ Iontophoresis System - Phoresor. A square wave will be delivered at 0.75 Hz for five blocks of five minutes each with one minute inter-train interval. Stimulation will be applied following 8 epochs of consecutive stage 2 or deeper sleep. |
| Sham tDCS stimulation | Sham comparator | Other: ShamtDCS electrodes will be applied bi-frontally using Chattanooga Ionto™ Iontophoresis System - Phoresor, however stimulation will never be turned on. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Students
- Adults aged 60 or greater.
Key exclusion criteria (5 listed)
- If they are taking any prescription or over the counter medications.
- If they have any currently active neurologic, psychiatric, hormonal, metabolic, circulatory, or sleep disturbances. -They must specifically not have a history of seizures, closed head injuries with loss of consciousness for greater than 5 minutes, any known brain tumors or lesions, metal implants or implanted devices above the neck, a history of eczema, or other sensitive conditions, or an allergy to latex.
- They must not smoke cigarettes, use illicit drugs, or meet criteria for alcohol abuse or dependence in their lifetime defined by SCID criteria.
- They must be free of alcohol for at least 48 hours prior to each night of the study
- They must not consume more than the equivalent of 500mg of caffeine daily.
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 |
|---|---|---|
| transcranial direct current stimulation (tDCS)tDCS is a type of brain stimulation that uses low current applied directly over the scalp to increase, or decrease cortical activity under the stimulating electrodes. tDCS applied bi-frontally using Chattanooga Ionto™ Iontophoresis System - Phoresor. A square wave will be delivered at 0.75 Hz for five blocks of five minutes each with one minute inter-train interval. Stimulation will be applied following 8 epochs of consecutive stage 2 or deeper sleep. | Device | Active tDCS stimulation |
| ShamtDCS device connected and tested, but not turned on during the night. This has been found to be an effective sham in other studies using this technique. | Other | Sham tDCS stimulation |
Primary outcome
Declarative memory assessed by paired word association test
Time frame: Pre sleep/intervention, and post sleep/intervention
Prior to and directly after a night of sleep we will assess declarative memory using a paired word association tests. In the pre-sleep assessment there will be a learning phase where the word list will be presented serially, until 60% of the words are retained. In the post sleep assessment the word list will be given again once. The outcome measure is the change in words retained between pre and post sleep assessments. Subsequently the followup interval is approximately 8-9 hours with baseline before bedtime, and follow up assessment once the patient is awoken.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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.
Gregory Sahlem, M.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Sleep, run by Medical University of South Carolina 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 5 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 30 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Declarative memory assessed by paired word association test (time frame: Pre sleep/intervention, and post sleep/intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2023.