Healthy Older AdultsTRAINSTIM1NCT02794259
tDCS Effects on GABA Concentration and Brain Functional Connectivity in Older Adults of Retirement Age
A study testing tDCS in people with Healthy Older Adults, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a decrease of GABA concentration and alterations of functional brain connectivity in older people, compared to sham tDCS. Read more about this study
- Who is it for?
- Ages 66 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Older Adults
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Aug 2016
- 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 66 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- unobtrusive neuropsychological screening
- age: older adults of retirement age: ≥66 years
Who cannot join
- Mild cognitive impairment (MCI) or other neurological diseases.
- History of severe alcoholism or use of drugs.
- Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
- Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on GABA Concentration and Brain Functional Connectivity in Older Adults
The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a decrease of GABA concentration and alterations of functional brain connectivity in older people, compared to sham tDCS.
- Conditions
- Healthy Older Adults
- Being tested
- tDCS, sham-tDCS
- Keywords
- GABA concentration, tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
sham-tDCSDevice
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | Anodal stimulation during resting state fMRI Receives: Device: tDCS |
| Cathodal tDCS | Experimental | Cathodal stimulation during resting state fMRI Receives: Device: tDCS |
| Sham tDCS | Sham comparator | Sham stimulation during resting state fMRI Receives: Device: sham-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
GABA concentration assessed by magnetic resonance spectroscopy (MRS) after anodal tDCS adjusted for baseline levels
Investigation whether anodal tDCS leads to a significant reduction of M1-GABA concentration in older adults compared to sham stimulation.
Measured: assessed immediately before and after a 15-min stimulation time
Secondary outcomes (3)
GABA concentration assessed by MRS before and after cathodal tDCS adjusted for baseline levels
To assess stimulation effects on GABA concentration by magnetic resonance spectroscopy are measured before and after cathodal tDCS.
Measured: assessed immediately before and after a 15-min stimulation time
Resting-state functional connectivity changes
Functional connectivity as measured by resting-state fMRI during tDCS compared to sham
Measured: assessed during a 15-min stimulation time
Genotyping of learning related polymorphisms
To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed
Measured: assessed during baseline screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy Older AdultsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)
- Responsible party
- Principal investigator, Agnes Flöel, Charite University, Berlin, Germany
- Investigators
- Agnes Flöel, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794259
- Sponsor's protocol ID
- TRAINSTIM1.A
- Acronym
- TRAINSTIM1
- Status last verified
- Jan 2017
- First submitted
- 5 Apr 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
Publications
Stagg CJ, Bachtiar V, Amadi U, Gudberg CA, Ilie AS, Sampaio-Baptista C, O'Shea J, Woolrich M, Smith SM, Filippini N, Near J, Johansen-Berg H. Local GABA concentration is related to network-level resting functional connectivity. Elife. 2014 Mar 25;3:e01465. doi: 10.7554/eLife.01465.
PubMed 24668166Bachtiar V, Near J, Johansen-Berg H, Stagg CJ. Modulation of GABA and resting state functional connectivity by transcranial direct current stimulation. Elife. 2015 Sep 18;4:e08789. doi: 10.7554/eLife.08789.
PubMed 26381352Amadi U, Allman C, Johansen-Berg H, Stagg CJ. The Homeostatic Interaction Between Anodal Transcranial Direct Current Stimulation and Motor Learning in Humans is Related to GABAA Activity. Brain Stimul. 2015 Sep-Oct;8(5):898-905. doi: 10.1016/j.brs.2015.04.010. Epub 2015 May 1.
PubMed 26279408
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) on GABA Concentration and Brain Functional Connectivity in Older Adults
- ClinicalTrials.gov ID
- NCT02794259
- Acronym / sponsor ID
- TRAINSTIM1 / TRAINSTIM1.A
- Conditions
- Healthy Older Adults
- Keywords
- GABA concentration, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Jun 2016 (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.
The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a decrease of GABA concentration and alterations of functional brain connectivity in older people, compared to sham tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: tDCSAnodal stimulation during resting state fMRI |
| Cathodal tDCS | Experimental | Device: tDCSCathodal stimulation during resting state fMRI |
| Sham tDCS | Sham comparator | Device: sham-tDCSSham stimulation during resting state fMRI |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- unobtrusive neuropsychological screening
- age: older adults of retirement age: ≥66 years
Key exclusion criteria (4 listed)
- Mild cognitive impairment (MCI) or other neurological diseases.
- History of severe alcoholism or use of drugs.
- Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
- Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).
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 |
|---|---|---|
| tDCS | Device | Anodal tDCS, Cathodal tDCS |
| sham-tDCS | Device | Sham tDCS |
Primary outcome
GABA concentration assessed by magnetic resonance spectroscopy (MRS) after anodal tDCS adjusted for baseline levels
Time frame: assessed immediately before and after a 15-min stimulation time
Investigation whether anodal tDCS leads to a significant reduction of M1-GABA concentration in older adults compared to sham stimulation.
3 secondary outcomes
GABA concentration assessed by MRS before and after cathodal tDCS adjusted for baseline levels
Time frame: assessed immediately before and after a 15-min stimulation time
Resting-state functional connectivity changes
Time frame: assessed during a 15-min stimulation time
Genotyping of learning related polymorphisms
Time frame: assessed during baseline screening
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 6 Jan 2017.
- Background: PubMed 24668166Stagg CJ, Bachtiar V, Amadi U, Gudberg CA, Ilie AS, Sampaio-Baptista C, O'Shea J, Woolrich M, Smith SM, Filippini N, Near J, Johansen-Berg H. Local GABA concentration is related to network-level resting functional connectivity. Elife. 2014 Mar 25;3:e01465. doi: 10.7554/eLife.01465.
- Background: PubMed 26381352Bachtiar V, Near J, Johansen-Berg H, Stagg CJ. Modulation of GABA and resting state functional connectivity by transcranial direct current stimulation. Elife. 2015 Sep 18;4:e08789. doi: 10.7554/eLife.08789.
- Background: PubMed 26279408Amadi U, Allman C, Johansen-Berg H, Stagg CJ. The Homeostatic Interaction Between Anodal Transcranial Direct Current Stimulation and Motor Learning in Humans is Related to GABAA Activity. Brain Stimul. 2015 Sep-Oct;8(5):898-905. doi: 10.1016/j.brs.2015.04.010. Epub 2015 May 1.
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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.
Agnes Flöel, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Healthy Older Adults, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 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 6 Jan 2017. 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 Germany. 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?
GABA concentration assessed by magnetic resonance spectroscopy (MRS) after anodal tDCS adjusted for baseline levels (time frame: assessed immediately before and after a 15-min stimulation time). 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 NCT02794259, which also lists 3 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 6 Jan 2017.