Corticobasal DegenerationST-CBSNCT05653778
Scrambler Therapy for Corticobasal Syndrome-Associated Pain
A study testing Scrambler therapy and TENS treatment in people with Corticobasal Degeneration and Corticobasal Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this pilot trial is to test whether scrambler therapy (ST) is an effective treatment for neuropathic pain in patients with corticobasal syndrome (CBS). The main question it aims to answer is: Will ST reduce pain scores by at least 33% at one month in this pilot trial, justifying further multi-center… Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Corticobasal Degeneration, Corticobasal Syndrome, Pain, Neuropathic
- What is being tested?
- Scrambler therapy and TENS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women, ≥50 years of age or older with CBS with an average daily pain rating of > 4 out of 10, using the following question from the Brief Pain Inventory: "Please rate your pain by circling the one number that best describes your (abdominal) pain/discomfort on average over the past week. (Scale 0-10; 0= No pain, 10= Pain as bad as you can imagine)
- English speakers or English proficiency
- They must have a life expectancy > 90 days per their treating neurologist.
- The patient must be able to understand the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Who cannot join
- Pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device, surgical sterilization, subcutaneous implants, abstinence, etc.). Other exclusions include the following:
- Use of an investigational agent for pain control concurrently or within the past 30 days,
- History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation;
- Patients with implantable drug delivery systems, e.g. Medtronic Synchromed, baclofen pumps.
- Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, cochlear implants, aneurysm clips, vena cava clips and skull plates. (Metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed).
- Medical exclusions include: patients with a history of myocardial infarction or ischemic heart disease within the past six months; patients with history of epilepsy, brain damage, or symptomatic brain metastases; skin conditions such as open sores that would prevent proper application of the electrodes; or other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Alexander Pantelyat, MD, 410-502-3290, apantel1@jhmi.edu
Maria Schmidt, CRNP, 410-502-0133, mschmi61@jhmi.edu
About this study
The goal of this pilot trial is to test whether scrambler therapy (ST) is an effective treatment for neuropathic pain in patients with corticobasal syndrome (CBS).
The main question it aims to answer is:
Read more
Will ST reduce pain scores by at least 33% at one month in this pilot trial, justifying further multi-center trials?
Participants will:
- be randomly assigned treatment from either transcutaneous electrical nerve stimulation (TENS) or ST for pain initially (eventually all patients will receive ST).
- have superficial electrocardiogram (ECG) electrodes placed on the dermatomes involved with pain
- obtain treatment lasting 30-40 minutes or until pain relief is obtained
Researchers will compare patient's response to pain relief with TENS and ST to determine if ST is an effective treatment for central neuropathic pain.
Read the detailed description
Pain can be a common non-motor complication of corticobasal syndrome (CBS), which is a rare debilitating parkinsonian disorder that lacks disease-modifying therapies. Pain in CBS typically increases in severity as the disease progresses and adversely impacts quality of life (including sleep and daily function). Scrambler therapy is a non-invasive electrical approach to neuromodulation that sends "nonpain" information along the existing nerve pathways to modify peripheral and central sensitization with success in randomized controlled trials treating such difficult neuropathies as spinal cord stenosis, post-herpetic neuropathy and failed back syndrome; chemotherapy induced neuropathy; and neuromyelitis optica spectrum disorder (NMOSD). To date, four patients with CBS treated empirically with ST have experienced long lasting pain relief with treatment, suggesting a novel approach to a vexing symptom.
An estimated 35-80% of patients with Parkinson disease experience pain and it is highly likely that pain is more frequent in CBS, though estimates are lacking because CBS is a rare syndrome. This pain can be related to dystonia, musculoskeletal, radicular-peripheral neuropathic, and central neuropathic pain syndromes. Similar symptoms are found in patients with CBS. Currently, there are no FDA approved disease-modifying treatments. Although treatments for pain have been helpful, ultimately adjunct therapies are needed as the disease progresses. A simple, low-cost, non-invasive available treatment to reduce the pain of CBS is sorely needed. This pilot trial will provide data on which to design a larger randomized controlled trial.
Research Hypothesis: Scrambler Therapy (ST) will reduce pain scores by at least 33% at one month in this pilot trial, justifying further multi-center trials.
- Being tested
- Scrambler therapy, TENS treatment
- Keywords
- Corticobasal Degeneration, scrambler therapy, Corticobasal syndrome, neuropathic pain, neuropathy
- Medical subject headings
- Corticobasal Degeneration, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scrambler therapyDevice
Superficial electrocardiogram (ECG) electrodes are placed on the dermatomes involved with pain, above the area of pain itself. Each treatment lasts 30-40 minutes or until pain relief is obtained.
TENS treatmentDevice
Superficial electrocardiogram (ECG) electrodes are placed on the dermatomes involved with pain, above the area of pain itself. Each treatment lasts 30-40 minutes or until pain relief is obtained.
| Study group | Role | What they receive |
|---|---|---|
| Scrambler therapy | Experimental | Scrambler Therapy is a non-invasive neuromodulation approach using superficial electrocardiogram (ECG) electrodes in paired channels on the involved dermatomes to send "non-pain" information along the existing nerve pathways, which can modify peripheral and central sensitization. Receives: Device: Scrambler therapy |
| TENS treatment | Active comparator | Transcutaneous electrical nerve stimulation (TENS) is a battery-powered device which delivers low-voltage electrical current through superficial electrocardiogram (ECG) electrodes placed on the surface of the skin to provide pain relief. Receives: Device: TENS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported average daily pain using the Modified Brief Pain Index
The primary objective is to determine the change in patient-reported average daily pain from Day 0 to Day 30 and 90 as measured on a numerical scale of 0-10 (0=no pain; 10=worst pain in life) using the Modified Brief Pain Index.
Measured: Day 0 to Day 30 and 90
Secondary outcomes (1)
Change in patient-reported Global Impression of Change (PGIC)
Changes in the Patient Global Impression of Change score 1 to 7 with 1 representing no change and 7 representing "a great deal better"
Measured: Day 0, Day 30 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start5 Apr 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corticobasal DegenerationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomly assigned scrambler therapy or TENS treatment to patients.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Pantelyat, MD, Principal investigator, Department of Neurology, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653778
- Sponsor's protocol ID
- IRB00343996
- Acronym
- ST-CBS
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2022
- Last updated
- 13 Jan 2026
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scrambler Therapy for Corticobasal Syndrome-Associated Pain
- ClinicalTrials.gov ID
- NCT05653778
- Acronym / sponsor ID
- ST-CBS / IRB00343996
- Keywords
- Corticobasal Degeneration, scrambler therapy, Corticobasal syndrome, neuropathic pain, neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 16 Dec 2022 (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 goal of this pilot trial is to test whether scrambler therapy (ST) is an effective treatment for neuropathic pain in patients with corticobasal syndrome (CBS).
The main question it aims to answer is:
Will ST reduce pain scores by at least 33% at one month in this pilot trial, justifying further multi-center trials?
Participants will:
- be randomly assigned treatment from either transcutaneous electrical nerve stimulation (TENS) or ST for pain initially (eventually all patients will receive ST).
- have superficial electrocardiogram (ECG) electrodes placed on the dermatomes involved with pain
- obtain treatment lasting 30-40 minutes or until pain relief is obtained
Researchers will compare patient's response to pain relief with TENS and ST to determine if ST is an effective treatment for central neuropathic pain.
Detailed description
Pain can be a common non-motor complication of corticobasal syndrome (CBS), which is a rare debilitating parkinsonian disorder that lacks disease-modifying therapies. Pain in CBS typically increases in severity as the disease progresses and adversely impacts quality of life (including sleep and daily function). Scrambler therapy is a non-invasive electrical approach to neuromodulation that sends "nonpain" information along the existing nerve pathways to modify peripheral and central sensitization with success in randomized controlled trials treating such difficult neuropathies as spinal cord stenosis, post-herpetic neuropathy and failed back syndrome; chemotherapy induced neuropathy; and neuromyelitis optica spectrum disorder (NMOSD). To date, four patients with CBS treated empirically with ST have experienced long lasting pain relief with treatment, suggesting a novel approach to a vexing symptom.
An estimated 35-80% of patients with Parkinson disease experience pain and it is highly likely that pain is more frequent in CBS, though estimates are lacking because CBS is a rare syndrome. This pain can be related to dystonia, musculoskeletal, radicular-peripheral neuropathic, and central neuropathic pain syndromes. Similar symptoms are found in patients with CBS. Currently, there are no FDA approved disease-modifying treatments. Although treatments for pain have been helpful, ultimately adjunct therapies are needed as the disease progresses. A simple, low-cost, non-invasive available treatment to reduce the pain of CBS is sorely needed. This pilot trial will provide data on which to design a larger randomized controlled trial.
Research Hypothesis: Scrambler Therapy (ST) will reduce pain scores by at least 33% at one month in this pilot trial, justifying further multi-center trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomly assigned scrambler therapy or TENS treatment to patients.
| Arm | Type | Receives |
|---|---|---|
| Scrambler therapy | Experimental | Device: Scrambler therapyScrambler Therapy is a non-invasive neuromodulation approach using superficial electrocardiogram (ECG) electrodes in paired channels on the involved dermatomes to send "non-pain" information along the existing nerve pathways, which can modify peripheral and central sensitization. |
| TENS treatment | Active comparator | Device: TENS treatmentTranscutaneous electrical nerve stimulation (TENS) is a battery-powered device which delivers low-voltage electrical current through superficial electrocardiogram (ECG) electrodes placed on the surface of the skin to provide pain relief. |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women, ≥50 years of age or older with CBS with an average daily pain rating of > 4 out of 10, using the following question from the Brief Pain Inventory: "Please rate your pain by circling the one number that best describes your (abdominal) pain/discomfort on average over the past week. (Scale 0-10; 0= No pain, 10= Pain as bad as you can imagine)
- English speakers or English proficiency
- They must have a life expectancy > 90 days per their treating neurologist.
- The patient must be able to understand the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Key exclusion criteria (6 listed)
- Pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device, surgical sterilization, subcutaneous implants, abstinence, etc.). Other exclusions include the following:
- Use of an investigational agent for pain control concurrently or within the past 30 days,
- History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation;
- Patients with implantable drug delivery systems, e.g. Medtronic Synchromed, baclofen pumps.
- Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, cochlear implants, aneurysm clips, vena cava clips and skull plates. (Metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed).
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 |
|---|---|---|
| Scrambler therapySuperficial electrocardiogram (ECG) electrodes are placed on the dermatomes involved with pain, above the area of pain itself. Each treatment lasts 30-40 minutes or until pain relief is obtained. | Device | Scrambler therapy |
| TENS treatmentSuperficial electrocardiogram (ECG) electrodes are placed on the dermatomes involved with pain, above the area of pain itself. Each treatment lasts 30-40 minutes or until pain relief is obtained. | Device | TENS treatment |
Primary outcome
Change in patient-reported average daily pain using the Modified Brief Pain Index
Time frame: Day 0 to Day 30 and 90
The primary objective is to determine the change in patient-reported average daily pain from Day 0 to Day 30 and 90 as measured on a numerical scale of 0-10 (0=no pain; 10=worst pain in life) using the Modified Brief Pain Index.
1 secondary outcome
Change in patient-reported Global Impression of Change (PGIC)
Time frame: Day 0, Day 30 and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- 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.
Alexander Pantelyat, MD principal investigator
Department of Neurology, Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scrambler therapy and TENS treatment in people with Corticobasal Degeneration and Corticobasal Syndrome, run by Johns Hopkins University 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Pantelyat, MD (410-502-3290, apantel1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported average daily pain using the Modified Brief Pain Index (time frame: Day 0 to Day 30 and 90). 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 13 Jan 2026.