Lyme Disease Patients With Memory Problems
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03500770|
Recruitment Status : Suspended (lack of funding)
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lyme Disease||Device: Transcranial Direct Current Stimulator||Not Applicable|
Lyme disease is a tick-borne illness caused by Borrellia Bugdorferi after tick bite. This disease mostly presents with a skin rash which looks like bulls eye and therefore known as bulls-eye skin rash or Erythema Migrans. The standard of care of Lyme disease is a few weeks of antibiotics. Most of the patients do well after antibiotics treatment. However 10-20% of patients go on to develop persistent symptoms such as memory problems, fatigue and pain several months after the antibiotics treatment. Such symptoms are collectively known as Post Treatment Lyme Disease Syndrome. In this study we want to see if a device known as Transcranial Direct Current Stimulator (tDCS) is helpful in reducing these symptoms after Lyme disease treatment.
This study will consist of a total of 13 visits. After determining eligibility criteria through pre-screening and labs we will schedule visit 1. During visit 1 we will ask the study participants to fill several questionnaire forms related to memory, pain, fatigue, quality of life, depression and headache etc. We will draw blood to measure certain lab markers. We will do a few other tests to determine brain oxygenation level and to check brain waves.
During next 10 visits we will administer small current through a device known as Transcranial Direct Current Stimulator. This device and the amount of current delivered is very safe. Visit 12 is fairly the same as visit 1 as we will ask the study participant to answer questions related to memory, quality of life, pain, fatigue, depression and headache. During this visit we will also do the test to determine oxygenation level of brain and will perform brain wave testing.
Visit 13 will be last and final visit which will occur one month after visit 12. During this final visit the study participant will be asked to answer the questions related to memory, quality of life, pain, fatigue, depression and headache. During this visit we will again measure oxygenation level of brain and perform brain wave testing.
By doing this study in total 13 visits we expect to find out if the device "Transcranial Direct Current Stimulator" is helpful in reducing these symptoms after Lyme disease treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transcranial Direct Current Stimulation (tDCS) for Cognitive Deficit, Fatigue and Pain in Patients With Post Treatment Lyme Disease Syndrome|
|Estimated Study Start Date :||February 20, 2019|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Transcranial Direct Current Stimulator
The Transcranial Direct Current Stimulator device (tDCS) is a safe technique which poses a non-significant risk to study subjects. This technique uses weak current which is applied by using two electrodes. In the literature, no undesirable or long-lasting side effects due to device have been reported, nor have any participants reportedly abandoned a study due to discomfort.
Device: Transcranial Direct Current Stimulator
The tDCS device to be used will be an investigational, battery powered, custom-made stimulator able to deliver a biphasic alternate current. Active stimulation consists of 10 active tDCS sessions with current intensity fixed at 2mA for 20 minutes. It has been safely used in several other research studies. The side effects profile for this type of stimulation include tingling/itching at the site of stimulation, skin irritation/redness at the site of stimulation, headache or dizziness.
- cognitive dysfunction [ Time Frame: up to 12 weeks ]CVLT test change from baseline
- Fatigue [ Time Frame: up to 12 weeks ]GSQ Questionnaire change from baseline
- Pain [ Time Frame: up to 12 weeks ]Analog scale pain level change from baseline
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): NCT03500770
|United States, Massachusetts|
|Cambridge, Massachusetts, United States, 02140|
|Principal Investigator:||Nevena Zubcevik, DO||Spaulding Rehabilitation Hospital|