Brain Stimulation for Alzheimer's Disease (STIM Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByBenjamin Hampstead, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This study will test the effects of different doses of a form of non-invasive brain stimulation for the treatment of individuals with mild cognitive impairment (MCI) and dementia of the Alzheimer's Type (DAT).
Will I have to stop taking my current medications?
The trial requires that you have been stable on your current medications for at least 4 weeks before joining, so you should not stop taking them.
How is HD-tDCS treatment different from other Alzheimer's treatments?
HD-tDCS (High Definition Transcranial Direct Current Stimulation) is unique because it is a non-invasive brain stimulation method that specifically targets brain areas with more precision than traditional methods, potentially improving memory and cognitive function in Alzheimer's patients without the side effects associated with drugs.
123810What data supports the effectiveness of the treatment HD-tDCS for Alzheimer's Disease?
Research suggests that transcranial direct current stimulation (tDCS), a non-invasive brain stimulation method, shows promise in improving cognitive function and memory in Alzheimer's patients. Studies indicate that tDCS is safe and may help slow down cognitive decline in Alzheimer's disease.
1371011Is brain stimulation for Alzheimer's disease safe for humans?
Transcranial Direct Current Stimulation (tDCS), including its high-definition version (HD-tDCS), is generally considered safe and well-tolerated in humans, with no serious adverse effects reported in over 33,200 sessions. However, some studies suggest it could potentially cause harm, so caution is advised.
456911Eligibility Criteria
This trial is for individuals with mild cognitive impairment or dementia of the Alzheimer's type who can have an MRI and don't have metal/electronic implants in their upper body/head. They must be stable on current medications for at least 4 weeks.Inclusion Criteria
My medications have not changed in the last 4 weeks.
I have been diagnosed with Mild Cognitive Impairment or Alzheimer's type dementia.
Exclusion Criteria
I have a specific neurological condition.
I have severe difficulty with my senses (sight, hearing, touch).
Participant Groups
The study tests non-invasive brain stimulation (HD-tDCS) at different doses (1 mA, 2 mA, and 3 mA) versus a sham treatment to see its effects on memory in people with cognitive issues related to Alzheimer's.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 3 mA Dosage StimulationExperimental Treatment1 Intervention
3 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Group II: 2 mA Dosage StimulationExperimental Treatment1 Intervention
2 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Group III: 1 mA Dosage StimulationExperimental Treatment1 Intervention
1 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Group IV: Sham StimulationPlacebo Group1 Intervention
Sham (placebo) dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
HD-tDCS is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as HD-tDCS for:
- Depression
- Anxiety disorders
- Cognitive enhancement
🇪🇺 Approved in European Union as HD-tDCS for:
- Major depressive disorder
- Chronic pain management
🇨🇦 Approved in Canada as HD-tDCS for:
- Depression
- Anxiety disorders
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
Loading ...
Who is running the clinical trial?
University of MichiganLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Transcranial direct current stimulation improves recognition memory in Alzheimer disease. [2022]To evaluate the cognitive effect of transcranial direct current stimulation (tDCS) over the temporoparietal areas in patients with Alzheimer disease (AD).
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.
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.
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.
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.
Transcranial Direct Current Stimulation Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis. [2020]The purpose of this meta-analysis was to evaluate the therapeutic effect of transcranial direct current stimulation (tDCS) on mild to moderate Alzheimer disease (AD) patients.
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.
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.
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.
Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. [2023]Few studies have investigated tolerability, blinding, and double-blinding of High-Definition transcranial Direct Current Stimulation (HD-tDCS) at amplitudes above 2 milliamps (mA).