tDCS for Cognitive Impairment
(AIM Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Must not be taking: GABAergic, Glutamatergic, Calcium blockers, Sodium blockers
Disqualifiers: Neurological disorders, Seizures, Psychiatric disorders, Cancer, others
Trial Summary
What is the purpose of this trial?The current study is a mechanistic study to evaluate working memory gains from application of transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control
Will I have to stop taking my current medications?
If you are currently taking GABAergic or glutamatergic medications, or calcium or sodium channel blockers, you will need to stop, as these medications interfere with the study.
What data supports the effectiveness of the treatment tDCS for cognitive impairment?
Research suggests that transcranial direct current stimulation (tDCS) may help improve cognitive functions like memory and processing speed in conditions such as Alzheimer's disease and mild cognitive impairment. However, the evidence is not yet strong enough to make definitive conclusions, and more large-scale studies are needed to confirm its effectiveness.
12345Is transcranial direct current stimulation (tDCS) safe for humans?
Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no serious adverse effects reported in over 33,200 sessions and 1,000 subjects, including vulnerable populations. Common side effects are mild and temporary, such as itching, tingling, and headaches.
678910How is the treatment tDCS different from other treatments for cognitive impairment?
Transcranial Direct Current Stimulation (tDCS) is unique because it is a noninvasive method that uses a mild electrical current to stimulate the brain, unlike traditional drug treatments. It is being explored for its potential to improve cognitive function in conditions like Alzheimer's disease and mild cognitive impairment without the use of medication.
123511Eligibility Criteria
This trial is for older adults aged 60-95 with mild cognitive impairments (MCI). Participants must be able to attend training sessions, receive electrical stimulation, understand conversational voices, and have the motor skills to use a computer mouse. A Montreal Cognitive Assessment score of 18 or above is required.Inclusion Criteria
I can use a computer mouse and click buttons without help.
Able to receive electrical stimulation
I am between 60 and 95 years old.
+3 more
Exclusion Criteria
Terminal illness with life expectancy less than 12 months, as determined by physician
I have a brain tumor or a foreign object in my brain.
Contraindications to MRI recording (e.g., any kind of ferrous metallic stents or ferrous metal objects in the body, heart valve prosthesis, or other metal implants, claustrophobia, neurostimulation system, defibrillator, pacemaker, or other implanted device)
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either active or sham tDCS stimulation to evaluate working memory gains
12 minutes per session, with sessions separated by at least two weeks
3 visits (in-person) per stimulation condition
Follow-up
Participants are monitored for changes in working memory performance and brain connectivity
4 weeks
Participant Groups
The AIM Pilot Study is testing whether transcranial direct current stimulation (tDCS) can improve working memory in older adults with MCI. The study compares active tDCS against sham tDCS (a placebo-like treatment) to see if there's a real benefit from the intervention.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
AA neuroConn MR-safe 1x1 tDCS stimulator will be used to apply 12 minutes of 2.0 mA electrical current, with 30 seconds ramps up and 30 seconds ramps down. The electrical current will be applied by using two carbon rubber electrodes (one anode, one cathode) with added ten20 conductive paste. The electrode+paste will be affixed on the participant's scalp over the frontal cortices at F3 and F4 location (EEG 10-20 system). Inflow of current (anode) will occur at F4 location, and outflow of current will occur at F3 (cathode).
Group II: Sham tDCSPlacebo Group1 Intervention
Sham stimulation will be performed with the same 1x1 device. Participants will receive 2 mA of direct current stimulation for 30 seconds with 30 seconds ramps up and down. This provides the tingling and prickling sensation on the scalp associated with tDCS while prevent delivering sufficient current (12 minutes) to penetrate the skull and stimulate the brain. Prep in sham conditions will be identical to active stimulation conditions. For each stimulation condition (active, sham), each participant will perform three runs of N-back working memory task (baseline/pre-stimulation, during stimulation, and after/post-stimulation) as detailed below. Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
References
Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]Transcranial direct current stimulation (tDCS) is a safe and well-tolerated noninvasive method for stimulating the brain that is rapidly developing into a treatment method for various neurological and psychiatric conditions. In particular, there is growing evidence of a therapeutic role for tDCS in ameliorating or delaying the cognitive decline in Alzheimer's disease (AD). We provide a brief overview of the current development and application status of tDCS as a nonpharmacological therapeutic method for AD and mild cognitive impairment (MCI), summarize the levels of evidence, and identify the improvements needed for clinical applications. We also suggest future directions for large-scale controlled clinical trials of tDCS in AD and MCI, and emphasize the necessity of identifying the mechanistic targets to facilitate clinical applications.
Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study. [2020]To investigate whether anodal and cathodal transcranial direct current stimulation (tDCS) can modify cognitive performance and neural activity in healthy elderly and Alzheimer's disease (AD) patients.
The Effects of Transcranial Direct Current Stimulation on the Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Pilot Study. [2022]The aim of this pilot study was to investigate whether the use of anodal transcranial direct current stimulation (tDCS) on the left dorsolateral prefrontal cortex could boost the effects of a cognitive stimulation (CS) programme using a tablet on five older adults with mild cognitive impairment (MCI).
Transcranial Direct Current Stimulation and Cognition in Neuropsychiatric Disorders: Systematic Review of the Evidence and Future Directions. [2022]Transcranial direct current stimulation (tDCS) has been implemented in neuropsychiatric disorders characterized by cognitive impairment. However, methodological heterogeneity challenges conclusive remarks. Through a critical analysis of previous conflicting findings and in the light of current neurobiological models of pathophysiology, we qualitatively assessed the effects of tDCS in neuropsychiatric disorders that share neurobiological underpinnings, as to evaluate whether stimulation can improve cognitive deficits in patients' cohorts. We performed a systematic review of tDCS studies targeting cognitive functions in mental disorders and pathological cognitive aging. Data from 41 studies, comprising patients with diagnosis of mood disorders, schizophrenia-spectrum disorders, Alzheimer's disease (AD), and mild cognitive impairment (MCI), were included. Results indicate that tDCS has the capacity to enhance processing speed, working memory, and executive functions in patients with mood and schizophrenia-spectrum disorders. The evidence of a positive effect on general cognitive functioning and memory is either inconclusive in AD, or weak in MCI. Future directions are discussed for developing standardized stimulation protocols and for translating the technique therapeutic potential into effective clinical practice.
Effects of multisession transcranial direct current stimulation as an augmentation to cognitive tasks in patients with neurocognitive disorders in Japan: a study protocol for a randomised controlled trial. [2021]Transcranial direct current stimulation (tDCS) is a potentially novel strategy for cognitive enhancement in patients with disorders. We present a study protocol for a randomised controlled trial designed to evaluate the safety and efficacy of tDCS combined with cognitive tasks on cognition in such patients.
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.
Safety of transcranial direct current stimulation in healthy participants. [2021]•Transcranial Direct Current Stimulation (tDCS) is mostly reported as safe.•BUT it could induce life-changing conditions in healthy volunteers.•Scientific community MUST be warned that tDCS may be harmful and protect healthy volunteers.
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation investigated as a treatment for several neuropsychiatric disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be low and transient, systematic review analyses on safety and tolerability of tDCS derive mostly from single-session studies.
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]Transcranial direct current stimulation (tDCS) is reported to induce irritating skin sensations and occasional skin injuries, which limits the applied tDCS dose. Additionally, tDCS hardware safety profile prevents high current delivery when skin resistance is high.
A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation that has been intensively investigated in clinical and cognitive neuroscience. Although the general impression is that tDCS is a safe technique with mild and transient adverse effects (AEs), human data on safety and tolerability are largely provided from single-session studies in healthy volunteers. In addition the frequency of AEs and its relationship with clinical variables is unknown. With the aim of assessing tDCS safety in different conditions and study designs, we performed a systematic review and meta-analysis of tDCS clinical trials. We assessed Medline and other databases and reference lists from retrieved articles, searching for articles from 1998 (first trial with contemporary tDCS parameters) to August 2010. Animal studies, review articles and studies assessing other neuromodulatory techniques were excluded. According to our eligibility criteria, 209 studies (from 172 articles) were identified. One hundred and seventeen studies (56%) mentioned AEs in the report. Of these studies, 74 (63%) reported at least one AE and only eight studies quantified AEs systematically. In the subsample reporting AEs, the most common were, for active vs. sham tDCS group, itching (39.3% vs. 32.9%, p>0.05), tingling (22.2% vs. 18.3%, p>0.05), headache (14.8% vs. 16.2%, p>0.05), burning sensation (8.7% vs. 10%, p>0.05) and discomfort (10.4% vs. 13.4%, p>0.05). Meta-analytical techniques could be applied in only eight studies for itching, but no definite results could be obtained due to between-study heterogeneity and low number of studies. Our results suggested that some AEs such as itching and tingling were more frequent in the tDCS active group, although this was not statistically significant. Although results suggest that tDCS is associated with mild AEs only, we identified a selective reporting bias for reporting, assessing and publishing AEs of tDCS that hinders further conclusions. Based on our findings, we propose a revised adverse effects questionnaire to be applied in tDCS studies in order to improve systematic reporting of tDCS-related AEs.
Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study. [2022]Transcranial direct current stimulation (tDCS) is a potentially novel strategy for cognitive enhancement in patients with mild or major neurocognitive disorders. This study aims to assess the safety and efficacy of tDCS during cognitive training on cognitive functioning in patients with mild or major neurocognitive disorders.