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

NCT03542383 | Completed FDA Device

• 2 other identifiers: 16-64CDMRP-GW150060
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Memory Disorders; Word Finding Difficulty

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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).

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

Secondary Outcomes (3)

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

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

• Change in the performance on the Semantic Selection Task

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

• Change in the performance on the Event Related Potential (ERP)

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

Study Arms (2)

Active HD tDCS

ACTIVE COMPARATOR

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 HD tDCS

SHAM COMPARATOR

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

Sham High Definition Transcranial Direct Current Stimulation DEVICE

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

Sham HD tDCS

High Definition Transcranial Direct Current Stimulation DEVICE

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

Active HD tDCS

Eligibility Criteria

• Age: 45 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

Callier Center for Communication Disorders at The University of Texas at Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Memory Disorders; Anomia

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Language Disorders; Communication Disorders

Study Officials

• John Hart, Jr, MD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The assessors, tDCS administrators, and participants are masked to group assignment. Active and sham tDCS parameters are set up at each session by an experimenter who does not have contact with the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants with Gulf War Illness and word finding difficulty will be randomly assigned to either receive active tDCS or sham.

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 31, 2018
• Study Start: February 1, 2017
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)