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Treatment of Memory Disorders in Gulf War Illness With High Definition Transcranial Direct Cortical Stimulation (GWI HDtDCS)

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ClinicalTrials.gov Identifier: NCT03542383
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
The University of Texas at Dallas

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.


Condition or disease Intervention/treatment Phase
Memory Disorders Word Finding Difficulty Device: High Definition Transcranial Direct Current Stimulation Device: Sham High Definition Transcranial Direct Current Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants with Gulf War Illness and word finding difficulty will be randomly assigned to either receive active tDCS or sham.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Treatment of Memory Disorders in Gulf War Illness With High Definition Transcranial Direct Cortical Stimulation
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : September 29, 2019
Estimated Study Completion Date : September 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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

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




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

  2. Change in the performance on the California Verbal Learning Test (CVLT) [ Time Frame: Beginning of HD tDCS/sham treatment, after HDtDCS/sham (2 weeks), at 3 month follow-up and 6 month follow-up ]
    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).


Secondary Outcome Measures :
  1. Change in the performance on the Semantic Object Retrieval Test (SORT) [ Time Frame: Beginning of HD tDCS/sham treatment, after HDtDCS/sham (2 weeks), at 3 month follow-up and 6 month follow-up ]
    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.

  2. Change in the performance on the Semantic Selection Task [ Time Frame: Beginning of HD tDCS/sham treatment, after HDtDCS/sham (2 weeks), at 3 month follow-up and 6 month follow-up ]
    This is a go/no-go task performed during EEG.

  3. Change in the performance on the Event Related Potential (ERP) [ Time Frame: Beginning of HD tDCS/sham treatment, after HDtDCS/sham (2 weeks), at 3 month follow-up and 6 month follow-up ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542383


Contacts
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Contact: Scott Shakal, BA 972-883-3171 scott.shakal@utdallas.edu
Contact: Kylee Yeatman, BS 972-883-3171 kylee.yeatman@utdallas.edu

Locations
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United States, Texas
Callier Center for Communication Disorders at The University of Texas at Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Sarah Sprinkle    972-883-3178    sarah.sprinkle@utdallas.edu   
Contact: Kylee Yeatman    972-883-3171    kylee.yeatman@utdallas.edu   
Sub-Investigator: Sven Vanneste, PhD         
Sub-Investigator: Jeffrey Spence, PhD         
Sub-Investigator: Michael Motes, PhD         
Sub-Investigator: Robert A. Haley, MD         
Sponsors and Collaborators
The University of Texas at Dallas
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: John Hart, Jr, MD The University of Texas at Dallas
  Study Documents (Full-Text)

Documents provided by The University of Texas at Dallas:

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Responsible Party: The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT03542383     History of Changes
Other Study ID Numbers: 16-64
CDMRP-GW150060 ( Other Grant/Funding Number: CDMRP )
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Any information shared with other researchers will be de-identified.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The University of Texas at Dallas:
Gulf War Illness
Memory
Word Finding
High Definition Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Memory Disorders
Disease
Signs and Symptoms
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases