Lyme DiseaseNCT03500770
Lyme Disease Patients With Memory Problems
A study testing Transcranial Direct Current Stimulator in people with Lyme Disease, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Disease
- What is being tested?
- Transcranial Direct Current Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) for Cognitive Deficit, Fatigue and Pain in Patients With Post Treatment Lyme Disease Syndrome
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.
Read the 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.
- Conditions
- Lyme Disease
- Being tested
- Transcranial Direct Current Stimulator
- Keywords
- Post Treatment Lyme Disease Syndrome
- Medical subject headings
- Lyme Disease, Post-Lyme Disease Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulator | Experimental | 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. Receives: Device: Transcranial Direct Current Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive dysfunction
CVLT test change from baseline
Measured: up to 12 weeks
Secondary outcomes (1)
Fatigue
GSQ Questionnaire change from baseline
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start20 Feb 2019 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevena Zubcevik, Spaulding Rehabilitation Hospital
- Investigators
- Nevena Zubcevik, DO, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500770
- Sponsor's protocol ID
- 2015P000309
- Status last verified
- Apr 2018
- First submitted
- 13 Oct 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) for Cognitive Deficit, Fatigue and Pain in Patients With Post Treatment Lyme Disease Syndrome
- ClinicalTrials.gov ID
- NCT03500770
- Acronym / sponsor ID
- 2015P000309
- Conditions
- Lyme Disease
- Keywords
- Post Treatment Lyme Disease Syndrome
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: lack of funding
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- 20 Feb 2019 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulator | Experimental | Device: Transcranial Direct Current StimulatorThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (24 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulatorThe 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. | Device | Transcranial Direct Current Stimulator |
Primary outcome
cognitive dysfunction
Time frame: up to 12 weeks
CVLT test change from baseline
1 secondary outcome
Fatigue
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevena Zubcevik, DO principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulator in people with Lyme Disease, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive dysfunction (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.