AzTrials
AzTrials

Memory DisordersGWI HDtDCSNCT03542383

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

A study testing High Definition Transcranial Direct Current Stimulation in people with Memory Disorders and Word Finding Difficulty, run by The University of Texas at Dallas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 78 years
Conditions the study is for
Memory Disorders, Word Finding Difficulty
What is being tested?
High Definition Transcranial Direct Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
1 siteUnited States
Study dates
1 Feb 2017to 29 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 78 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 informed consent 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

Who cannot join

  • 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 informed consent.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Callier Center for Communication Disorders at The University of Texas at Dallas

    Dallas, Texas, 75235

Other trials in United States

About this study

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).

Being tested
High Definition Transcranial Direct Current Stimulation, Sham High Definition Transcranial Direct Current Stimulation
Keywords
Gulf War Illness, Memory, Word Finding, High Definition Transcranial Direct Current Stimulation, Transcranial Direct Current Stimulation
Medical subject headings
Memory Disorders, Anomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Definition Transcranial Direct Current StimulationDevice

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

  • Sham High Definition Transcranial Direct Current StimulationDevice

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

Study groups in NCT03542383
Study groupRoleWhat they receive
Active HD tDCSActive comparatorAdminister 10 20-minute sessions of 1 mA anodal High Definition Transcranial Direct Current Stimulation to the preSMA region over a two week period.
Receives: Device: High Definition Transcranial Direct Current Stimulation
Sham HD tDCSSham comparatorAdminister 10 20-minute sessions of sham High Definition Transcranial Direct Current Stimulation to the preSMA region over a two week period.
Receives: Device: Sham High Definition Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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).

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

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2018
  2. Study start1 Feb 2017
  3. Primary completion29 Sep 2025
  4. Study completion29 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants with Gulf War Illness and word finding difficulty will be randomly assigned to either receive active tDCS or sham.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03542383
Sponsor's protocol ID
16-64
Other IDs
CDMRP-GW150060
Acronym
GWI HDtDCS
Status last verified
Jan 2026
First submitted
7 May 2018
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Any information shared with other researchers will be de-identified.

Questions about this trial

What is this clinical trial studying?

A study testing High Definition Transcranial Direct Current Stimulation in people with Memory Disorders and Word Finding Difficulty, run by The University of Texas at Dallas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in performance on the Controlled Oral Word Association Test (COWAT) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in