Transcranial Stimulation for Memory Loss (GWI HDtDCS Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByJohn Hart, Jr, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas at Dallas
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?A debilitating and common symptom in Gulf War Illnesses (GWI) is the inability to retrieve words. This affects one's conversations, ability to fluidly exchange information verbally and retrieve information from memory. The investigators have discovered 3 brain regions - the PreSupplementary Motor Area (preSMA), caudate nucleus, and the thalamus - that are essential for word retrieval. They have also detected abnormal EEG signals related to these regions in GWI patients who have problems retrieving words.
The investigators have used their model of verbal retrieval to design a noninvasive, nonpharmacological treatment that uses High Definition transcranial Direct Current Stimulation (HD tDCS). Using HD tDCS, they deliver small amounts of electric current to areas of the head to stimulate specific brain regions. The objective is to determine if delivery of HD tDCS over the preSMA will improve performance in GWI veterans with a verbal retrieval deficit. The investigators will administer pre-treatment tests of verbal retrieval measures while recording brain electrical activity. They will then administer 10 sessions of HD tDCS over the preSMA (20 minutes a session) in half the veterans. The other half will go through the same procedures, except the current will not be turned on (called the sham condition). The investigators will then compare performance between the "active" and sham group and assess if the treatment had a significant effect on performing verbal retrieval tasks and if there is a change in the ERP markers to account for how the treatment worked. If the treatment is found to be effective it will be offered to those in the sham group at the study's end.
The investigators predict this treatment regimen will lead to positive effects on a person's daily functions, especially improved conversational abilities, with few, if any, side effects. They hope to outline the standard procedures for physicians to perform the treatment by creating a manual on how to apply the treatment in a clinical setting so that it will be quickly available to use in multiple sites if the proposed study demonstrates that it is efficacious. This treatment can be made widely available for Warrior Transition Units, military clinics, and VA medical centers. In addition, if successful, this could potentially lead to development of other targets of stimulation to improve other cognitive deficits in GWI, and help alleviate verbal fluency deficits associated with other disorders.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that interact with the treatment, such as amphetamines, L-dopa, and citalopram, among others. It's important to discuss your current medications with the study team to determine if any changes are necessary.
How is the treatment HD-tDCS different from other treatments for memory loss?
HD-tDCS is unique because it uses weak electric currents delivered through multiple electrodes to target specific brain areas, potentially enhancing memory by modulating brain activity. Unlike traditional treatments, it offers a non-invasive approach that can be tailored to stimulate particular brain regions associated with memory.
48101112Is transcranial stimulation 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 across various studies. However, some studies suggest that it could potentially cause significant issues, so caution is advised, especially for healthy individuals.
236912What data supports the effectiveness of the treatment High Definition Transcranial Direct Current Stimulation (HD-tDCS) for memory loss?
Research shows that transcranial direct current stimulation (tDCS), a similar treatment, can enhance memory and learning in both young and older adults. Studies have found that tDCS can improve immediate memory, learning potential, and working memory, and it has been shown to help with memory recall and consolidation over multiple sessions.
1571012Eligibility Criteria
This trial is for US Gulf War veterans who served between 1990-1991, are right-handed, and were aged 18-50 during service. Participants must understand English and be able to consent. Excluded are those with neurological disorders, severe TBI, drug abuse history, certain medication use, pacemakers or metal in the head.Inclusion Criteria
I served in the Gulf War and was between 18 and 50 years old at that time.
Exclusion Criteria
I am not fluent in English.
I have a history of serious brain conditions or injuries.
I don't have a pacemaker, medication pumps, severe heart disease, or non-removable metal near my head.
I am not taking any medication that affects brain stimulation therapy.
I am able to understand and agree to the study's procedures and risks.
Participant Groups
The study tests High Definition transcranial Direct Current Stimulation (HD tDCS) on brain regions linked to word retrieval in Gulf War Illness patients. It compares active HD tDCS against a sham (inactive) treatment over ten sessions to see if it improves verbal abilities.
2Treatment groups
Active Control
Placebo Group
Group I: Active HD tDCSActive Control1 Intervention
Administer 10 20-minute sessions of 1 mA anodal High Definition Transcranial Direct Current Stimulation to the preSMA region over a two week period.
Group II: Sham HD tDCSPlacebo Group1 Intervention
Administer 10 20-minute sessions of sham High Definition Transcranial Direct Current Stimulation to the preSMA region over a two week period.
High Definition Transcranial Direct Current Stimulation is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as HD-tDCS for:
- Investigational for various neurological conditions, including depression, chronic pain, and cognitive enhancement
🇪🇺 Approved in European Union as HD-tDCS for:
- Investigational for various neurological conditions, including depression, chronic pain, and cognitive enhancement
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Callier Center for Communication Disorders at The University of Texas at DallasDallas, TX
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Who is running the clinical trial?
The University of Texas at DallasLead Sponsor
University of Texas Southwestern Medical CenterCollaborator
References
Learning, memory, and transcranial direct current stimulation. [2021]Transcranial direct current stimulation (tDCS) has been the subject of many studies concerning its possible cognitive effects. One of the proposed mechanisms of action for neuromodulatory techniques, such as transcranial magnetic stimulation and tDCS is induction of long-term potentiation (LTP) and long-term depression (LTD)-like phenomena. LTP and LTD are also among the most important neurobiological processes involved in memory and learning. This fact has led to an immediate interest in the study of possible effects of tDCS on memory consolidation, retrieval, or learning of various tasks. This review analyses published articles describing beneficial or disruptive effects of tDCS on memory and learning in normal subjects. The most likely mechanisms underlying these effects are discussed.
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.
Transcranial stimulation over the left inferior frontal gyrus increases false alarms in an associative memory task in older adults. [2020]Transcranial direct current stimulation (tDCS) is a potential tool for alleviating various forms of cognitive decline, including memory loss, in older adults. However, past effects of tDCS on cognitive ability have been mixed. One important potential moderator of tDCS effects is the baseline level of cognitive performance.
Differential Age Effects of Transcranial Direct Current Stimulation on Associative Memory. [2020]Older adults experience associative memory deficits relative to younger adults (Old & Naveh-Benjamin, 2008). The aim of this study was to test the effect of transcranial direct current stimulation (tDCS) on face-name associative memory in older and younger adults.
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.
Multisession transcranial direct current stimulation facilitates verbal learning and memory consolidation in young and older adults. [2021]This study investigated effects of multisession transcranial direct-current stimulation on learning and maintenance of novel memory content and scrutinised effects of baseline cognitive status and the role of multi-session tDCS on overnight memory consolidation. In a prospective, randomized, double-blind, parallel-group, sham-tDCS controlled design, 101 healthy young and older adults completed a five-day verbal associative learning paradigm while receiving multisession tDCS to the task-relevant left prefrontal cortex. In older adults, active multisession tDCS enhanced recall performance after each daily training session. Effects were maintained the next morning and during follow-up assessments (one week; three months). In young adults, multisession tDCS significantly increased long-term recall. Unlike previous findings in the motor domain, beneficial effects of multisession tDCS on cognitive learning and memory were notexclusively due to enhanced memory consolidation. Positive stimulation effects were primarily found in participants with lower baseline learning ability, suggesting that multisession tDCS may counteract memory impairment in health and disease.
Transcranial Direct Current Stimulation Enhances Episodic Memory in Healthy Older Adults by Modulating Retrieval-Specific Activation. [2021]Memory decline has become an issue of major importance in the aging society. Anodal transcranial direct current stimulation (atDCS) is a viable tool to counteract age-associated episodic memory deterioration. However, the underlying neural mechanisms are unclear. In this single-blind, sham-controlled study, we combined atDCS and functional magnetic resonance imaging to assess the behavioral and neural consequences of multiple-session atDCS in older adults. Forty-nine healthy older adults received either 10 sessions of anodal or sham stimulation over the left dorsolateral prefrontal cortex. Before and after stimulation, participants performed a source memory task in the MRI scanner. Compared to sham stimulation, atDCS significantly improved item memory performance. Additionally, atDCS significantly increased regional brain activity around the stimulation area in the prefrontal cortex and extended to the bilateral anterior cingulate cortex. Neural changes in the prefrontal cortex correlated with memory gains. Our findings therefore indicate that multiple-session offline atDCS may improve memory in older adults by inducing neural alterations.
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.
Enhancing Immediate Memory, Potential Learning, and Working Memory with Transcranial Direct Current Stimulation in Healthy Older Adults. [2023]Transcranial direct current stimulation (tDCS) has emerged as a prevention method or minimizer of the normal cognitive deterioration that occurs during the aging process. tDCS can be used to enhance cognitive functions such as immediate memory, learning, or working memory in healthy subjects. The objective of this study was to analyze the effect of two 20-min sessions of anodal transcranial direct stimulation on immediate memory, learning potential, and working memory in healthy older adults.
High-definition transcranial direct current stimulation (HD-tDCS) for the enhancement of working memory - A systematic review and meta-analysis of healthy adults. [2023]High-definition transcranial direct current stimulation (HD-tDCS) administers weak electric current through multiple electrodes, enabling focal brain stimulation. An increasing number of studies investigate the effects of anodal HD-tDCS on the enhancement of working memory (WM). The effectiveness of the technique is, however, still unclear.
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).