ClinicalTrials.gg
CompletedNCT03542383GWI HDtDCSUpdated Jan 16, 2026

Treatment of Memory Disorders in Gulf War Illness With High Definition Transcranial Direct Cortical Stimulation

An interventional study of High Definition Transcranial Direct Current Stimulation and Sham High Definition Transcranial Direct Current Stimulation in Memory Disorders and Word Finding Difficulty, sponsored by The University of Texas at Dallas. Completed at 1 site in United States. Open to participants aged 45 Years to 78 Years. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2025, 1 year 1 month ago, and no results have been posted to the registry.
  • Registered 1 year 3 months after the study started (first participant enrolled Feb 2017, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
45 Years to 78 Years
Sex
All
01

Study summary

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.

Read the detailed description

The objective of this proposal is to identify patients with GWI who have a verbal retrieval deficit and determine if delivery of HD tDCS over the PreSupplementary Motor Area of the brain (preSMA) will improve performance in verbal retrieval-related tasks.

Key cognitive symptom described by patients with GWI extends from a disruption in the cognitive process of verbal retrieval. This is manifested in a variety of dysfunctions including word retrieval deficits, verbal fluency disruption and potentially verbal episodic memory. The investigators have delineated a circuit of verbal retrieval using functional neuroimaging and electrophysiology measures in normal controls and in patient populations showing that a circuit of the preSMA-caudate nucleus-thalamus is essential for effective retrieval of verbal information. This model has generated specific ERP neural markers of successful verbal retrieval and we have studied GWI patients with dysfunction in these ERP and functional MRI markers.

In addition, patients with MS and TBI have been treated by the investigators for similar verbal retrieval deficits as those with GWI by using the technique of High Definition transcranial Direct Current Stimulation (HD tDCS) over the preSMA region to strengthen the connections of this retrieval circuit.

The investigators hypothesize that application of 1 ma anodal HD tDCS over the preSMA for 20 minutes a session for 10 sessions over a two week period will lead to improvement in verbal retrieval that will be detectable in both performance measures of verbal retrieval tasks and in ERP markers of verbal retrieval processing. The objective is to determine if 10 sessions of 1 ma anodal HD tDCS to the preSMA for 20 minutes a session are an effective treatment for verbal retrieval deficits in GWI.

The goal of this proposal is to entrain the verbal retrieval circuit using HD tDCS to target the preSMA in order to improve retrieval in impaired GWI patients, using behavioral and electrophysiological markers to assess outcomes. After identifying GWI patients with retrieval deficits using standard neuropsychological measures, the following aims will be addressed:

Aim 1. Administer 10 20-minute sessions of either 1 mA high definition tDCS or sham to the preSMA region.

Subtypes of Gulf War Illness patients have been shown to have dysfunction that disrupts the above-described retrieval circuit. Transcranial DCS targeted to the preSMA has been shown in preliminary studies in other diseased populations to result in improved performance in tasks that engage this circuit by purportedly strengthening potentially weak connections within the preSMA-caudate-thalamus circuit for verbal retrieval.

Hypothesis #1:HD tDCS to the preSMA will produce long-term modulation of the basal state of the preSMA-caudate-thalamic-cortical retrieval circuit.

Aim 2. Assess neuropsychological and electrophysiological (ERP) markers of verbal retrieval following tDCS therapy. Long-term modulation of the preSMA-caudate-thalamic-cortical retrieval circuit, via tDCS to the preSMA region, will alter the neurophysiological properties of the circuit due to modulation of the readiness of the retrieval circuit. This will result in changes in neural markers as follows:

Hypothesis #2a: Neuropsychological measures of verbal retrieval that were impaired at baseline will be improved to expected premorbid levels of functioning for the treated individuals.

Hypothesis #2b: Patients with impairments in making a correct retrieval will exhibit both high false negative errors and false positive errors compared to norms and a decreased 750-ms ERP amplitude difference between retrievals and nonretrievals on the SORT task. The investigators hypothesize that after HD tDCS treatment, these patients will improve performance and/or have an increase in amplitude difference in the ERP between retrievals and nonretrievals.

Hypothesis #2c: An increase in false negative errors and a decreased "Go" P3 ERP response on the Semantic Selection Tasks is indicative of an impaired ability to select a correct memory for retrieval. Conversely, there will be increased false positive errors and a decreased "NoGo" P3 ERP on the Semantic Selection Tasks if a patient cannot inhibit an incorrect memory. The investigators hypothesize that following HD tDCS therapy, there will be a normalization of the patient's behavior (reduced errors, improved RTs) and/or ERP responses (increased P3 amplitudes for Go and/or NoGo trials) due to modulation of the retrieval circuit, with the changes based on the pre-treatment impaired retrieval function (selection and/or inhibition).

02

Conditions studied

  • Memory Disorders
  • Word Finding Difficulty

Keywords

  • Gulf War Illness
  • Memory
  • Word Finding
  • High Definition Transcranial Direct Current Stimulation
  • Transcranial Direct Current Stimulation
03

In context

Memory Disorders

373 studies on the registry are indexed under Memory Disorders; 67 are open to participants now.

This study's enrollment of 93 is above the median of 72 across 298 interventional studies indexed under Memory Disorders.

Browse Memory Disorders studies →

Lead sponsor

The University of Texas at Dallas is the lead sponsor of 60 studies on the registry; 19 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 78 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • US military veterans serving during the 1990-1991 GW and were deployed to the theater of operations in Southwest Asia (i.e., Iraq, Kuwait, and Saudi Arabia) who are capable of understanding and signing an document.
  • between the ages of 18 and 50 years old DURING SERVICE in the Gulf War (born between 1940 and 1973).
  • Any gender, race/ethnicity, and both enlisted and officer ranks will be included.
  • English speakers because not all of the screening forms, questionnaires, and tests are available in languages other than English.
  • right-handed

Exclusion criteria

Exclusion Criteria:

  • non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except English.
  • a history of a neurological disorder, including dementia of any type, moderate to severe traumatic brain injury (TBI), brain tumors, present or past drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, Huntington's disease, or multiple sclerosis. Traumatic brain injury will be screened by history.
  • anyone cognitively or clinically incompetent to give .
  • taking medications that interact with the tDCS effect including amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole,or citalopram.
  • cardiac pacemakers, implanted medication pumps of any sort, or a history of bad heart disease, and/or the presence of any metal objects in or near the head which cannot be safely removed for the duration of this study which could be affected by tDCS or affect the administration of tDCS.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
93 participants (actual)

Study arms

  • Active comparator
    Active HD tDCS

    Administer 10 20-minute sessions of 1 mA anodal High Definition Transcranial Direct Current Stimulation to the preSMA region over a two week period.

    Device: High Definition Transcranial Direct Current Stimulation

  • Sham comparator
    Sham HD tDCS

    Administer 10 20-minute sessions of sham High Definition Transcranial Direct Current Stimulation to the preSMA region over a two week period.

    Device: Sham High Definition Transcranial Direct Current Stimulation

Interventions

  • DeviceHigh Definition Transcranial Direct Current Stimulation

    Administer 1 ma anodal HD tDCS over the preSMA for 20 minutes a session for 10 sessions over a two week period

  • DeviceSham High Definition Transcranial Direct Current Stimulation

    Administer sham HD tDCS over the preSMA for 20 minutes a session for 10 sessions over a two week period

06

What researchers measure

Primary outcomes

  1. Change in performance on the Controlled Oral Word Association Test (COWAT)

    The COWAT is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter.

    Time frame: Phone screen, beginning of HD tDCS/sham treatment, after HDtDCS/sham (2 weeks), at 3 month follow-up and 6 month follow-up.

  2. Change in the performance on the California Verbal Learning Test (CVLT)

    The CVLT is a measure of episodic verbal learning and memory. The test does this by attempting to link memory deficits with impaired performance on specific tasks. It assesses encoding, recall and recognition in a single modality of item presentation (auditory-verbal).

    Time frame: Beginning of HD tDCS/sham treatment, after HDtDCS/sham (2 weeks), at 3 month follow-up and 6 month follow-up

Secondary outcomes

  1. Change in the performance on the Semantic Object Retrieval Test (SORT)

    The SORT was developed for the assessment of semantic memory and subsequent name production, and has been shown to detect word retrieval deficits in other neurological diseases.

    Time frame: Beginning of HD tDCS/sham treatment, after HDtDCS/sham (2 weeks), at 3 month follow-up and 6 month follow-up

  2. Change in the performance on the Semantic Selection Task

    This is a go/no-go task performed during EEG.

    Time frame: Beginning of HD tDCS/sham treatment, after HDtDCS/sham (2 weeks), at 3 month follow-up and 6 month follow-up

  3. Change in the performance on the Event Related Potential (ERP)

    ERP is the measured brain response that is the direct result of a specific sensory, cognitive, or motor event. This provides a noninvasive means of evaluating brain functioning. ERPs are measured by electroencephalography (EEG).

    Time frame: Beginning of HD tDCS/sham treatment, after HDtDCS/sham (2 weeks), at 3 month follow-up and 6 month follow-up

07

Study locations

1 site
  • Callier Center for Communication Disorders at The University of Texas at Dallas
    Dallas, Texas 75235, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Any information shared with other researchers will be de-identified.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Sep 2025, 103 months.

Of 129 non-industry interventional studies with no phase under Memory Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 53. This study's 103 months is above that.

Counting every sponsor, half of 138 studies reached it within 35 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2018
First posted
May 31, 2018
StartActual
Feb 1, 2017
Primary completionActual
Sep 29, 2025
CompletionActual
Sep 29, 2025
Last update
Jan 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03542383
Lead sponsor
The University of Texas at Dallas
Responsible party
John Hart, Jr. (Professor, The University of Texas at Dallas) — Principal investigator
First posted
May 31, 2018
Start date
Feb 1, 2017
Primary completion
Sep 29, 2025
Completion
Sep 29, 2025
Last update
Jan 16, 2026

Study contacts

John Hart, Jr, MD
principal investigator · The University of Texas at Dallas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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