Noninvasive Brain Stimulation for Alzheimer's Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston University Charles River Campus
Must be taking: Cholinesterase inhibitors
Disqualifiers: Stroke, Traumatic brain injury, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The investigators will evaluate the theory that Alzheimer's disease-related memory impairment derives from the inefficient orchestration of rhythmic activity at the level of large-scale cortical networks. The results as expected to elucidate AD-related pathophysiology and set groundwork for the development of drug-free interventions for improving memory in AD and related dementias.
Will I have to stop taking my current medications?
The trial allows participants to continue taking certain medications, including antidepressants, Alzheimer's medications, and various heart and blood pressure medications. However, if you are on medications not listed, it's best to check with the trial coordinators.
What data supports the effectiveness of the treatment for Alzheimer's disease?
Research suggests that transcranial direct current stimulation (tDCS), a noninvasive method of brain stimulation, may help improve cognitive function and slow cognitive decline in people with Alzheimer's disease. Studies have shown improvements in memory and cognitive stability, indicating potential benefits of this treatment.
12345Is noninvasive brain stimulation safe for humans?
Transcranial direct current stimulation (tDCS), including its high-definition version (HD-tDCS), is generally considered safe and well-tolerated for various neurological and psychiatric conditions, with any adverse effects being low and temporary.
12678How does noninvasive brain stimulation differ from other treatments for Alzheimer's disease?
Noninvasive brain stimulation, specifically transcranial direct current stimulation (tDCS), is unique because it uses a mild electrical current to stimulate the brain without the need for medication. This method is non-pharmacological, meaning it doesn't involve drugs, and it aims to improve cognitive function and delay cognitive decline in Alzheimer's patients.
1291011Eligibility Criteria
This trial is for people aged 50-100 with Alzheimer's or mild cognitive impairment due to Alzheimer's, having certain memory performance scores. Healthy individuals can join if they meet specific cognitive norms. Participants must not have severe mental health issues, significant past brain conditions, or be on excluded medications.Inclusion Criteria
Do you have a diagnosis of Mild Cognitive Impairment or Alzheimer's disease?
Exclusion Criteria
Have you ever had a diagnosis of epilepsy, or do you have current or past history of seizures?
Do you have a history of neurological problems such as stroke or head injury such as traumatic brain injury?
Do you have any skin sensitivity on your face or scalp (the study involves placing a fabric cap, several electrodes and some water-soluble gel at these sites)?
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive low-intensity, high-definition, transcranial electrical current stimulation while performing computer-based tasks
1 year
Follow-up
Participants are monitored for memory performance and cognitive function after treatment
4 weeks
Participant Groups
The study tests whether noninvasive brain stimulation using high definition transcranial electrical current can improve memory in those with Alzheimer's by affecting rhythmic activity in the brain. It aims to pave the way for drug-free treatments.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: active stimulationExperimental Treatment1 Intervention
Memory performance data is collected during active brain stimulation and reported 1 year later
Group II: sham stimulationPlacebo Group1 Intervention
Memory performance data is collected during sham brain stimulation and reported 1 year later
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
111 Cummington Mall, Rm. 251Boston, MA
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Who Is Running the Clinical Trial?
Boston University Charles River CampusLead 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.
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.
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).
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).
Can 8 months of daily tDCS application slow the cognitive decline in Alzheimer's disease? A case study. [2018]This case study presents a patient with early-onset Alzheimer`s disease, who applied transcranial direct current stimulation (tDCS) daily for 8 consecutive months. This was a much higher frequency than previous tDCS studies. Neuropsychological assessments were conducted before the first tDCS session, after 5 months and after 8 months. After 8 months, the patient's immediate recall improved with 39%, whereas delayed recall improved 23%. Overall, the results revealed that patient's cognitive functions were stabilized. There may be slight possibility that tDCS could slow the cognitive decline in Alzheimer`s disease. This should be investigated in clinical trials.
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).
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.
Ameliorative Effects of Different Transcranial Electrical Stimulation Paradigms on the Novel Object Recognition Task in a Rat Model of Alzheimer Disease. [2022]Treatment of Alzheimer as a disease that is associated with cognitive impairment has been associated with some restrictions. Recently, researchers have focused on non-pharmacological treatments, including non-invasive stimulation of the brain by transcranial electrical stimulation (tES). Four main paradigms of transcranial electrical current include transcranial direct current stimulation (tDCS), transcranial alternative current stimulation (tACS), transcranial random noise stimulation (tRNS), transcranial pulse current stimulation (tPCS). The tDCS is a possible new therapeutic option for patients with cognitive impairment, including Alzheimer disease.
Efficacy and safety of simultaneous rTMS-tDCS over bilateral angular gyrus on neuropsychiatric symptoms in patients with moderate Alzheimer's disease: A prospective, randomized, sham-controlled pilot study. [2023]Treating neuropsychiatric symptoms (NPS) in Alzheimer's disease (AD) remains highly challenging. Noninvasive brain stimulation using repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) is of considerable interest in this context.
Neurostimulation for cognitive enhancement in Alzheimer's disease (the NICE-AD study): a randomized clinical trial. [2022]New therapies for symptoms in Alzheimer's disease (AD) are urgently needed. Prior studies suggest that transcranial direct current stimulation (tDCS), a noninvasive neuromodulatory method, may be a safe and potentially effective treatment, but conclusions have been limited by small-sample sizes and brief stimulation protocols. This double-blind randomized trial involving 100 older adults with mild-to-moderate AD examines effects of 6 months of at-home active tDCS or sham delivered over the dorsolateral prefrontal cortex. The primary outcome is global cognitive performance. Secondary outcomes include executive-control/spatial selective attention, functional neuroplasticity, depressive symptoms, quality of life and the durability of effects 3 months after the stimulation period. The results will provide evidence on the efficacy of multimonth at-home tDCS in the AD treatment. =Clinical trial identifier NCT04404153 (Clinicaltrials.gov).