Mild Cognitive ImpairmentNCT03441152
The Effects of Transcranial Direct Current Stimulation in Mild Cognitive Impairment
A study testing tDCS in people with Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Objectives: 1) To examine whether the real transcranial direct current stimulation (tDCS) group would perform better in the cognitive training (CT) intervention than the sham tDCS group and the CT group; 2) To determine if, as a consequence of the stimulation generated by the use of tDCS, there would be a transfer… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- 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
- 66 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2017to 30 Aug 2018
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria will follow the modified Petersen's criteria:
- Aged between 60 and 85 years old;
- Obtaining a score on the Montreal Cognitive Assessment Test (MoCA) between 19 and 26;
- Achieving a score on the Clinical Dementia Rating (CDR) of 0.5 or below ;
- Self-reported cognitive decline by the participants themselves and
- Being independent in daily living activities.
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- Additional criteria in this study include:
- Having completed three or more years of primary education;
- Ability to participate in a therapy session lasting at least 30 minutes;
- Community ambulant with or without aids; and
- Ability to perform a proper range of motion with hands in order to use a tablet PC.
Who cannot join
- 1) Individuals presenting with a diagnosis of dementia or any other neurological disease; (2) Individuals with depression determined by a score on Geriatric Depression Scale of >5, (3) History of drug or alcohol abuse or dependence in the last 3 months; and (4) Participants who had metallic fixtures around the cephalic area or skin lesions in the areas at where the electrodes were going to be attached were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neural Effects of Multisession Transcranial Direct Current Stimulation in Older Adults at Risk for Mild Cognitive Impairment and Its Impact in Cognitive Functions and Everyday Memory: A Randomized Controlled Trial
Objectives: 1) To examine whether the real transcranial direct current stimulation (tDCS) group would perform better in the cognitive training (CT) intervention than the sham tDCS group and the CT group; 2) To determine if, as a consequence of the stimulation generated by the use of tDCS, there would be a transfer effect to other cognitive domains and to cognitive tasks in activities of daily living; 3) To investigate the time and spatial responses of tDCS on the brain cortex during and after tDCS application.
Hypothesis to be tested: By applying anodal tDCS with the combination of a CT delivered via the use of tablet PCs in older adults at risk of MCI, it will enhance their cognitive task performance in CT and subsequently generalize to other cognitive domains as well, involving a transferability to cognitive tasks in activities of daily living.
Read more
Design and subjects: A multi-centered single-blinded randomized controlled trial (RCT) with three groups (CT alone/Sham tDCS with the combination of a CT/ Real tDCS coupling with CT) The participants who will take part of this study will be older adults at risk of MCI Study instruments: tDCS, Ipad, Neuron Up CT Apps, EEG. Interventions: The intervention will last for 9 sessions (3 sessions per week for 3 weeks). Sham tDCS and real tDCS, will be combined with the same CT which is used in the CT group. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT.
Main outcome measures: Cognitive assessments, CT performance, EEG. In addition, delta and theta frequency suppression and alpha increment power under the anode electrode will be observed.
- Conditions
- Mild Cognitive Impairment
- Being tested
- tDCS
- Keywords
- Mild Cognitive Impairment, Neuromodulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| tDCS+CT | Experimental | application of tDCS in combination with CT Receives: Device: tDCS |
| Sham tDCS | Sham comparator | application of sham tDCS in combination with CT Receives: Device: tDCS |
| CT | Active comparator | application of CT Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia.
Measured: 10 minutes
Digit Span Test
The test measures short term memory in such a way that sequences of digits are presented and have to be recalled in forward and reverse order. Testing ends when the maximal list length is reached or when subjects fail to recall the trial at one sequence length.
Measured: 10 minutes
Trial Making Test (TMT)
TMT encompasses visual attention and processing speed, it consists of 2 parts in which a set of 25 dots in the first part and 24 dots in the second part have to be accurately connected. Time performance is measured as the main outcome
Measured: 5 minutes
Secondary outcomes (1)
Riverhead Behavioral Memory Test (3rd edition) (RBMT-3)
It includes 14 subtests assessing aspects of visual, verbal, recall, recognition, immediate and delayed everyday memory. Additionally prospective memory skills and the ability to learn new information are measured as well
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jul 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth N. K. Fong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441152
- Sponsor's protocol ID
- HongKongPUPabloRS
- Status last verified
- Jan 2023
- First submitted
- 5 Feb 2018
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gonzalez PC, Fong KNK, Brown T. Transcranial direct current stimulation as an adjunct to cognitive training for older adults with mild cognitive impairment: A randomized controlled trial. Ann Phys Rehabil Med. 2021 Sep;64(5):101536. doi: 10.1016/j.rehab.2021.101536. Epub 2021 Jul 20.
PubMed 33957292
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Effects of Multisession Transcranial Direct Current Stimulation in Older Adults at Risk for Mild Cognitive Impairment and Its Impact in Cognitive Functions and Everyday Memory: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03441152
- Acronym / sponsor ID
- HongKongPUPabloRS
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 22 Feb 2018 (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.
Objectives: 1) To examine whether the real transcranial direct current stimulation (tDCS) group would perform better in the cognitive training (CT) intervention than the sham tDCS group and the CT group; 2) To determine if, as a consequence of the stimulation generated by the use of tDCS, there would be a transfer effect to other cognitive domains and to cognitive tasks in activities of daily living; 3) To investigate the time and spatial responses of tDCS on the brain cortex during and after tDCS application.
Hypothesis to be tested: By applying anodal tDCS with the combination of a CT delivered via the use of tablet PCs in older adults at risk of MCI, it will enhance their cognitive task performance in CT and subsequently generalize to other cognitive domains as well, involving a transferability to cognitive tasks in activities of daily living.
Design and subjects: A multi-centered single-blinded randomized controlled trial (RCT) with three groups (CT alone/Sham tDCS with the combination of a CT/ Real tDCS coupling with CT) The participants who will take part of this study will be older adults at risk of MCI Study instruments: tDCS, Ipad, Neuron Up CT Apps, EEG. Interventions: The intervention will last for 9 sessions (3 sessions per week for 3 weeks). Sham tDCS and real tDCS, will be combined with the same CT which is used in the CT group. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT.
Main outcome measures: Cognitive assessments, CT performance, EEG. In addition, delta and theta frequency suppression and alpha increment power under the anode electrode will be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS+CT | Experimental | Device: tDCSapplication of tDCS in combination with CT |
| Sham tDCS | Sham comparator | Device: tDCSapplication of sham tDCS in combination with CT |
| CT | Active comparator | Device: tDCSapplication of CT |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The inclusion criteria will follow the modified Petersen's criteria:
Key exclusion criteria (1 listed)
- 1) Individuals presenting with a diagnosis of dementia or any other neurological disease; (2) Individuals with depression determined by a score on Geriatric Depression Scale of >5, (3) History of drug or alcohol abuse or dependence in the last 3 months; and (4) Participants who had metallic fixtures around the cephalic area or skin lesions in the areas at where the electrodes were going to be attached were excluded from the study.
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 |
|---|---|---|
| tDCSTranscranial direct current stimulation | Device | CT, Sham tDCS, tDCS+CT |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: 10 minutes
It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia.
Digit Span Test
Time frame: 10 minutes
The test measures short term memory in such a way that sequences of digits are presented and have to be recalled in forward and reverse order. Testing ends when the maximal list length is reached or when subjects fail to recall the trial at one sequence length.
Trial Making Test (TMT)
Time frame: 5 minutes
TMT encompasses visual attention and processing speed, it consists of 2 parts in which a set of 25 dots in the first part and 24 dots in the second part have to be accurately connected. Time performance is measured as the main outcome
1 secondary outcome
Riverhead Behavioral Memory Test (3rd edition) (RBMT-3)
Time frame: 40 minutes
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 2 Feb 2023.
- Derived from this study: PubMed 33957292Gonzalez PC, Fong KNK, Brown T. Transcranial direct current stimulation as an adjunct to cognitive training for older adults with mild cognitive impairment: A randomized controlled trial. Ann Phys Rehabil Med. 2021 Sep;64(5):101536. doi: 10.1016/j.rehab.2021.101536. Epub 2021 Jul 20.
- Individual participant dataSharing planned: Undecided
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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 tDCS in people with Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 11 inclusion and 1 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 2 Feb 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 Hong Kong. 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?
Montreal Cognitive Assessment (MoCA) (time frame: 10 minutes). 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 NCT03441152, 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 2 Feb 2023.