Brain Stimulation for Dementia
(COBALT 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 Texas Southwestern Medical Center
Must not be taking: Medications altering HD-tDCS
Disqualifiers: Epilepsy, Brain tumor, Substance use, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This is a pilot study being done to attempt to improve episodic memory problems in persons with mild cognitive impairment (MCI) or dementia. The pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (dACC) have been shown to play a role in episodic memory and language retrieval. Prior studies have suggested that neurostimulation targeting this region can improve episodic memory and word recall. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/dACC region and its influence on word retrieval and other cognitive functions in patients with MCI or dementia. Entraining the preSMA/dACC circuit with 10 sessions of HD-tDCS will allow us to study whether neurostimulation may be an effective treatment.
Will I have to stop taking my current medications?
The trial excludes participants who are currently using medications known to alter the effects of the brain stimulation treatment. If you're on such medications, you may need to stop taking them to participate.
What data supports the effectiveness of the treatment NeuroElectric StarStim, HD-tDCS, Transcranial Direct Current Stimulation, High-Definition tDCS for dementia?
Research suggests that transcranial direct current stimulation (tDCS) may help improve cognitive performance and slow cognitive decline in Alzheimer's disease, a type of dementia. Studies have shown that combining tDCS with cognitive exercises can enhance brain activity and cognitive function in patients with Alzheimer's.
12345Is brain stimulation for dementia safe for humans?
Transcranial Direct Current Stimulation (tDCS), including its high-definition version, is generally considered safe in humans, with no serious adverse effects reported in over 33,200 sessions across various populations, including potentially vulnerable groups like the elderly. However, some studies suggest it may cause skin irritation or other minor, temporary side effects.
678910How is the NeuroElectric StarStim treatment different from other dementia treatments?
NeuroElectric StarStim, or HD-tDCS, is unique because it uses high-definition transcranial direct current stimulation to specifically target brain areas, potentially improving cognitive function by altering brain activity and connectivity without the side effects of drugs.
23111213Eligibility Criteria
This trial is for individuals aged 55 or older who are fluent in English and have been diagnosed with mild cognitive impairment or dementia. It's open to all genders and ethnicities. People can't join if they've had major neurological conditions, substance use disorders within the last year, metal fragments in their head, sensory impairments affecting testing, or take medications that affect brain stimulation.Inclusion Criteria
I have been diagnosed with mild cognitive impairment or dementia.
I am either a man or a woman.
I am 55 years old or older.
+2 more
Exclusion Criteria
I am taking medication that affects brain stimulation treatments.
Substance use disorder within the past year
Has metal fragments in skull/head
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Phase 1
Participants receive 10 sessions of active or sham HD-tDCS targeting preSMA/dACC over 2 weeks
2 weeks
10 visits (in-person)
Follow-up Phase 1
Participants complete word retrieval and cognitive tasks immediately after session 10 and at a 2-month follow-up
2 months
Treatment Phase 2
Participants from the sham group receive 10 sessions of active HD-tDCS after 2 months
2 weeks
10 visits (in-person)
Follow-up Phase 2
Participants complete word retrieval and cognitive tasks immediately after the last HD-tDCS session and at a 2-month follow-up
2 months
Participant Groups
The study tests whether a brain stimulation device called NeuroElectric StarStim can improve memory and language in people with memory problems due to MCI or dementia. Participants will receive either real neurostimulation targeting specific brain areas or a sham (fake) treatment as part of the research.
3Treatment groups
Active Control
Placebo Group
Group I: Phase 2: Active TreatmentActive Control1 Intervention
For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months from completing Phase 1. They will receive the active treatment while being unblinded to their treatment condition. Following 10 active treatment sessions, word retrieval and other cognitive tasks will again be completed immediately following the last HD-tDCS session and then a 2-month follow-up.
Group II: Phase 1: Active TreatmentActive Control1 Intervention
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up
Group III: Phase 1: Sham TreatmentPlacebo Group1 Intervention
Participants will receive 10 sessions of sham stimulation across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up
NeuroElectric StarStim is already approved in United States for the following indications:
🇺🇸 Approved in United States as NeuroElectric StarStim for:
- Investigational for mild cognitive impairment (MCI) and dementia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Southwestern Medical CenterDallas, TX
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Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor
Texas Alzheimer's Research and Care ConsortiumCollaborator
TEXAS ALZHEIMER'S RESEARCH & CARE CONSORTIUMCollaborator
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.
Combined Effects of tDCS and Language/Cognitive Intervention on the Naming of Dementia Patients: A Systematic Review and Meta-Analysis. [2022]The evidence of transcranial direct current stimulation (tDCS) treatment effects on dementia is still insufficient. This study aimed to prove the scientific basis of tDCS by conducting a meta-analysis of previous studies that examined the effects of tDCS on the naming of patients with dementia.
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.
Effects of multisite anodal transcranial direct current stimulation combined with cognitive stimulation in patients with Alzheimer's disease and its neurophysiological correlates: A double-blind randomized clinical trial. [2022]We aimed to examine the effects of multisite anodal transcranial direct current stimulation (tDCS) combined with cognitive stimulation (CS) over 2 months on cognitive performance and brain activity, and the relationship between them, in patients with Alzheimer's disease (AD).
A double-blind randomized clinical trial on the efficacy of cortical direct current stimulation for the treatment of Alzheimer's disease. [2022]The purpose of this study was to investigate the long-term efficacy of transcranial direct current stimulation (tDCS) in the neurorehabilitation of Alzheimer's disease (AD).
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.
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 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.
Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]Transcranial direct current stimulation (tDCS) is an in-demand form of neuromodulation generally regarded as safe and well tolerated. However, few studies have examined the safety, tolerability, or blinding of High Definition (HD-) tDCS, especially in older adults and at stimulation intensities of 2 milliamps (mA) or greater.
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.
Transcranial stimulation in depression. [2021]Transcranial direct current stimulation is coming of age with the large treatment study published in this issue. We review transcranial stimulation methods, their efficacy and the likely impact on National Health Service (NHS) practice. Their use in individuals who do not respond to or cannot tolerate medication should now be explored in large controlled naturalistic studies in the NHS.
Action mechanisms of transcranial direct current stimulation in Alzheimer's disease and memory loss. [2021]The pharmacological treatment of Alzheimer's disease (AD) is often limited and accompanied by drug side effects. Thus alternative therapeutic strategies such as non-invasive brain stimulation are needed. Few studies have demonstrated that transcranial direct current stimulation (tDCS), a method of neuromodulation with consecutive robust excitability changes within the stimulated cortex area, is beneficial in AD. There is also evidence that tDCS enhances memory function in cognitive rehabilitation in depressive patients, Parkinson's disease, and stroke. tDCS improves working and visual recognition memory in humans and object-recognition learning in the elderly. AD's neurobiological mechanisms comprise changes in neuronal activity and the cerebral blood flow (CBF) caused by altered microvasculature, synaptic dysregulation from ß-amyloid peptide accumulation, altered neuromodulation via degenerated modulatory amine transmitter systems, altered brain oscillations, and changes in network connectivity. tDCS alters (i) neuronal activity and (ii) human CBF, (iii) has synaptic and non-synaptic after-effects (iv), can modify neurotransmitters polarity-dependently, (v) and alter oscillatory brain activity and (vi) functional connectivity patterns in the brain. It thus is reasonable to use tDCS as a therapeutic instrument in AD as it improves cognitive function in manner based on a disease mechanism. Moreover, it could prove valuable in other types of dementia. Future large-scale clinical and mechanism-oriented studies may enable us to identify its therapeutic validity in other types of demential disorders.
Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. [2022]High-definition transcranial direct current stimulation (HD-tDCS) may allow more specific neural modulation than conventional-tDCS.