Treatment of Memory Disorders in Gulf War Illness With High Definition Transcranial Direct Cortical Stimulation (GWI HDtDCS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03542383|
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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.|
|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|
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
- 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.
- 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).
- 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.
- 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.
- 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).
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
|Contact: Scott Shakal, BAfirstname.lastname@example.org|
|Contact: Kylee Yeatman, BSemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Kylee Yeatman 972-883-3171 email@example.com|
|Sub-Investigator: Sven Vanneste, PhD|
|Sub-Investigator: Jeffrey Spence, PhD|
|Sub-Investigator: Michael Motes, PhD|
|Sub-Investigator: Robert A. Haley, MD|
|Principal Investigator:||John Hart, Jr, MD||The University of Texas at Dallas|