RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-02-01
Study Completion:2024-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03542383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 78 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * between the ages of 18 and 50 years old DURING SERVICE in the Gulf War (born between 1940 and 1973).
  3. * Any gender, race/ethnicity, and both enlisted and officer ranks will be included.
  4. * English speakers because not all of the screening forms, questionnaires, and tests are available in languages other than English.
  5. * right-handed
  1. * non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except English.
  2. * 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.
  3. * anyone cognitively or clinically incompetent to give informed consent.
  4. * taking medications that interact with the tDCS effect including amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole,or citalopram.
  5. * 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.

Contacts and Locations

Study Contact

Ellen Morris, PhD
CONTACT
972-883-3171
neurolab@utdallas.edu
Jill Ritter, BS
CONTACT
972-883-3171
jill.ritter@utdallas.edu

Principal Investigator

John Hart, Jr, MD
PRINCIPAL_INVESTIGATOR
The University of Texas at Dallas

Study Locations (Sites)

Callier Center for Communication Disorders at The University of Texas at Dallas
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: The University of Texas at Dallas

  • John Hart, Jr, MD, PRINCIPAL_INVESTIGATOR, The University of Texas at Dallas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-02-01
Study Completion Date2024-09-29

Study Record Updates

Study Start Date2017-02-01
Study Completion Date2024-09-29

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Memory Disorders
  • Word Finding Difficulty