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Lyme Disease Patients With Memory Problems

Primary Purpose

Lyme Disease

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulator
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lyme Disease focused on measuring Post Treatment Lyme Disease Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Fifteen subjects will be selected to take part in this study. All subjects must meet the following criteria:

  • Inclusion criteria:

    1. Age over 18 years, both males and females
    2. History of Lyme disease as diagnosed per CDC criteria and/or evidence of Erythema Migrans or diagnosis of Lyme disease as documented in medical record by an experienced health care practitioner.
    3. Meet defining criteria of Post Treatment Lyme Disease Syndrome (PTLDS) proposed by Infectious Diseases Society of America (IDSA)
    4. Ability to give informed consent as assessed by study physician
    5. Willing to participate in 10 tDCS sessions over two week period
    6. If on long-term antibiotics or supplements for treatment of Lyme disease must be willing to keep treatment regimen consistent during participation in the study
  • Exclusion criteria:

    1. Evidence of any active Borrelia infection or co-infection such as Babesiois, Anaplasmosis, Erhlichiosis, Ricketsia as assessed by serum serology, such patient will be referred to ID
    2. Evidence of current or prior infection by B. Mioymoti or B. hemsii, such patients will be referred to ID
    3. Any of the exclusion criteria of Post Treatment Lyme Disease Syndrome (PTLDS) as proposed by Infectious Diseases Society of America (IDSA)
    4. History of other chronic inflammatory conditions such as:

      • Rheumatoid arthritis
      • Asthma
      • Autoimmune diseases
      • Chronic prostatitis
      • Glomerulonephritis
      • Celiac disease
      • Inflammatory bowel disease
      • Pelvic inflammatory disease
      • Interstitial cystitis
      • Vasculitis
    5. Existence of major neurologic or psychiatric condition such as epilepsy, severe depression or others
    6. Past history of neurosurgery
    7. History of significant alcohol or drug abuse during previous 6 months
    8. Presence of unstable medical conditions such as uncontrolled diabetes mellitus, cardiac pathology, cancer, kidney insufficiency, acute thrombosis or others
    9. Any new medication or dosage changes in the past 60 days interfering with your symptoms related to PTLDS
    10. Concurrent use of opioids or narcotics which cause CNS suppression, cognitive or motor slowing
    11. Concurrent use of muscle relaxants
    12. Concurrent use of anti-epileptics such as Carbamazepine
    13. Pregnancy as assessed by urine pregnancy test
    14. Contraindication to tDCS such as metal in the head or implanted electronic medical devices.

Sites / Locations

  • Nevena Zubcevik

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Direct Current Stimulator

Arm Description

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.

Outcomes

Primary Outcome Measures

cognitive dysfunction
CVLT test change from baseline

Secondary Outcome Measures

Fatigue
GSQ Questionnaire change from baseline

Full Information

First Posted
October 13, 2016
Last Updated
April 16, 2018
Sponsor
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03500770
Brief Title
Lyme Disease Patients With Memory Problems
Official Title
Transcranial Direct Current Stimulation (tDCS) for Cognitive Deficit, Fatigue and Pain in Patients With Post Treatment Lyme Disease Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Suspended
Why Stopped
lack of funding
Study Start Date
February 20, 2019 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to see if a device known as Transcranial Direct Current Stimulator (tDCS) is helpful in reducing persistent symptoms after Lyme disease treatment. Some of these symptoms include problems with memory, fatigue or pain.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
Keywords
Post Treatment Lyme Disease Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulator
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
cognitive dysfunction
Description
CVLT test change from baseline
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Fatigue
Description
GSQ Questionnaire change from baseline
Time Frame
up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Pain
Description
Analog scale pain level change from baseline
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Fifteen subjects will be selected to take part in this study. All subjects must meet the following criteria: Inclusion criteria: Age over 18 years, both males and females History of Lyme disease as diagnosed per CDC criteria and/or evidence of Erythema Migrans or diagnosis of Lyme disease as documented in medical record by an experienced health care practitioner. Meet defining criteria of Post Treatment Lyme Disease Syndrome (PTLDS) proposed by Infectious Diseases Society of America (IDSA) Ability to give informed consent as assessed by study physician Willing to participate in 10 tDCS sessions over two week period If on long-term antibiotics or supplements for treatment of Lyme disease must be willing to keep treatment regimen consistent during participation in the study Exclusion criteria: Evidence of any active Borrelia infection or co-infection such as Babesiois, Anaplasmosis, Erhlichiosis, Ricketsia as assessed by serum serology, such patient will be referred to ID Evidence of current or prior infection by B. Mioymoti or B. hemsii, such patients will be referred to ID Any of the exclusion criteria of Post Treatment Lyme Disease Syndrome (PTLDS) as proposed by Infectious Diseases Society of America (IDSA) History of other chronic inflammatory conditions such as: Rheumatoid arthritis Asthma Autoimmune diseases Chronic prostatitis Glomerulonephritis Celiac disease Inflammatory bowel disease Pelvic inflammatory disease Interstitial cystitis Vasculitis Existence of major neurologic or psychiatric condition such as epilepsy, severe depression or others Past history of neurosurgery History of significant alcohol or drug abuse during previous 6 months Presence of unstable medical conditions such as uncontrolled diabetes mellitus, cardiac pathology, cancer, kidney insufficiency, acute thrombosis or others Any new medication or dosage changes in the past 60 days interfering with your symptoms related to PTLDS Concurrent use of opioids or narcotics which cause CNS suppression, cognitive or motor slowing Concurrent use of muscle relaxants Concurrent use of anti-epileptics such as Carbamazepine Pregnancy as assessed by urine pregnancy test Contraindication to tDCS such as metal in the head or implanted electronic medical devices.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevena Zubcevik, DO
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nevena Zubcevik
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lyme Disease Patients With Memory Problems

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