Stiff-Person SyndromeNCT06242678
Evaluating Spinal Cord Stimulation for Stiff Person Syndrome
A study testing SCS trial lead in people with Stiff-Person Syndrome, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this prospective pilot study is to gather preliminary evidence evaluating spinal cord stimulation (SCS) as a potential therapy for the treatment of rigidity and painful spasms in patients with stiff person syndrome (SPS), a rare autoimmune neurological condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stiff-Person Syndrome
- What is being tested?
- SCS trial lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 27 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Is 18 years of age or older at the time that the Informed Consent Form (ICF) is signed.
- Has been clinically diagnosed with stiff person syndrome
- Has clinical symptoms of muscle rigidity and spasms in the truncal (including abdominal, thoracic paraspinal, and pectoral) or proximal lower limb musculature
- Has Cerebrospinal fluid (CSF) Anti-glutamic acid decarboxylase 65 (anti-GAD65) antibodies or serum anti-GAD65 antibodies present at any titer
- Is currently trying or has tried in the past at least two conventional therapies with insufficient symptomatic relief or intolerable side effects (such as nonsteroidal anti- inflammatory drugs, topical patches/creams/gels/ointments, physical therapy, acupuncture, bracing, assistive devices, and lifestyle modification).
- If taking oral medications, is willing to maintain a stable regimen for the duration of the study period.
Show all 10Show fewer
- Is cleared for an implantable medical device by licensed mental health provider.
- Is an appropriate candidate for the surgical procedures required in this study based on clinical judgement of the study physician.
- Is willing to and capable of giving written informed consent.
- Is willing and able to comply with study-related requirements and procedures and attend scheduled visits.
Who cannot join
- Is less than 18 years of age at the time at the time that the Informed Consent Form (ICF) is signed.
- Has a Body Mass Index (BMI) > 45.
- Has a history of spine surgery or is planning to receive a spinal injection or procedure while participating in the study, unless this procedure can be postponed until after study completion.
- Has radiological findings or evidence of moderate to severe central spinal canal stenosis or neuroforaminal stenosis at any thoracic level or laterality.
- Has radiological findings or evidence of moderate/severe central spinal canal stenosis at any cervical or lumbar level.
- Has had an epidural steroid injection within 6 weeks of enrollment.
Show all 20Show fewer
- Has a history of infection of the spine within 6 months of enrollment.
- Has received intravenous immunoglobulin therapy within 30 days or is unwilling to maintain a stable regimen (no change in dosage or frequency) during the study period.
- Has a history of opioid misuse or current chronic opioid therapy.
- Has evidence of a coagulation abnormality or low platelet count (<120,000) indicated on Complete Blood Count test at screening, or has a history of abnormal bleeding, or if unable to pause anticoagulation therapy in accordance with accepted guidelines for a spinal cord stimulator trial.
- Has a current local infection at the anticipated surgical entry site, active systemic infection, or active malignancy.
- Has a medical condition or pain in other area(s) not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as radicular pain, post-herpetic neuralgia, central canal stenosis of the cervical, thoracic or lumbar spine, critical limb ischemia due to peripheral vascular disease, or small vessel disease).
- Has a history of untreated major depressive disorder, or history of any mental health disorder with psychotic features, such as schizophrenia.
- Is pregnant (confirmed via pregnancy test) or plans on becoming pregnant during the study period.
- Has had, within six months of enrollment, a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
- Is concomitantly participating in another interventional clinical trial.
- Is involved in an injury claim for a study-related chronic pain that is under current litigation.
- Is a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to study related chronic pain.
- Has a pending or approved worker's compensation claim for study-related chronic pain.
- Has low English language literacy interfering with the ability to complete study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
The purpose of this prospective pilot study is to gather preliminary evidence evaluating spinal cord stimulation (SCS) as a potential therapy for the treatment of rigidity and painful spasms in patients with stiff person syndrome (SPS), a rare autoimmune neurological condition. The hypothesis is that SCS-mediated clinical improvement occurs through multi-modal mechanisms of action targeting several components of neuronal inhibitory signaling pathways in the spinal cord.
Read the detailed description
The hypothesis is that SCS-mediated clinical improvement occurs through multi-modal mechanisms of action targeting several components of neuronal inhibitory signaling pathways in the spinal cord.
- Conditions
- Stiff-Person Syndrome
- Being tested
- SCS trial lead
- Medical subject headings
- Stiff-Person Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCS trial leadDevice
placement of spinal cord stimulator trial leads to see if effective in the management of symptoms associated with stiff person syndrome
| Study group | Role | What they receive |
|---|---|---|
| SCS trial lead | Experimental | placement of spinal cord stimulator trial leads Receives: Device: SCS trial lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
baseline pain will be measured on a 0-100 scale, with 100 being the worse level of pain, with improvement in pain level measured immediately prior to removal (kept in up to 10 days), with pain level reassessed at 14 days after trial leads removed to see if returned to baseline
Measured: Baseline
Pain Scores
baseline pain will be measured on a 0-100 scale, with 100 being the worse level of pain, with improvement in pain level measured immediately prior to removal (kept in up to 10 days), with pain level reassessed at 14 days after trial leads removed to see if returned to baseline
Measured: Day 24
Michigan Body Map
The Michigan Body Map (MBM) is a self-report measure to assess body areas of chronic pain with each area of pain marked is scored 1 point. Scores range from 0 to 35, with higher scores indicating more widespread body pain - Maximum score is 35. Higher score denotes more painful areas. It identifies the exact location of the area of recurrent or persistent pain. This map allows for accurate assessment of localized pain and widespread body pain to individualize pain management and track pain progress.
Measured: baseline
Michigan Body Map
The Michigan Body Map (MBM) is a self-report measure to assess body areas of chronic pain with each area of pain marked is scored 1 point. Scores range from 0 to 35, with higher scores indicating more widespread body pain - Maximum score is 35. Higher score denotes more painful areas. It allows a patient to identify the exact location of the area(s) of recurrent or persistent pain. This map allows for accurate assessment of localized pain and widespread body pain to individualize pain management and track pain progress.
Measured: up to day 10
Penn Spasm Frequency and Severity Scale
The first component is a 5 point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour". The second component is a 3 point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe"
Measured: Baseline
Penn Spasm Frequency and Severity Scale
The first component is a 5 point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour". The second component is a 3 point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe"
Measured: up to day 10
Pain Disability Index
The Pain Disability Index (PDI) is a self-report questionnaire that measures the impact of pain on a person's life. The PDI is scored on a scale of 0 to 70, with higher scores indicating a greater degree of disability:
0: No disability 10: Total disability
The PDI is made up of seven items, each rated on a scale of 0 to 10:
Family/home, Recreation, Social activity, Occupation, Sexual behavior, Self-care, and Life-support activity.
Measured: Baseline
Pain Disability Index
The Pain Disability Index (PDI) is a self-report questionnaire that measures the impact of pain on a person's life. The PDI is scored on a scale of 0 to 70, with higher scores indicating a greater degree of disability:
0: No disability 10: Total disability
The PDI is made up of seven items, each rated on a scale of 0 to 10:
Family/home, Recreation, Social activity, Occupation, Sexual behavior, Self-care, and Life-support activity.
Measured: up to Day 10
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is used to evaluate the overall subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Seven components, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. Maximum score is 21, indicative of poor sleep quality. Higher scoring denotes more difficulty in sleep - The global Pittsburgh Sleep Quality Index (PSQI) score ranges from 0 to 21
Measured: Baseline
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is used to evaluate the overall subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Seven components, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. Maximum score is 21, indicative of poor sleep quality. Higher scoring denotes more difficulty in sleep - The global Pittsburgh Sleep Quality Index (PSQI) score ranges from 0 to 21
Measured: up to Day 10
Fatigue Severity Scale (FSS) Scores
The FSS is a nine-item questionnaire that uses a seven-point Likert scale to score responses. The scale ranges from 1, which means "strongly disagree," to 7, which means "strongly agree". The minimum score is 9 and the maximum score is 63. A higher score indicates more severe fatigue.
Measured: baseline
Fatigue Severity Scale (FSS) Scores
The FSS is a nine-item questionnaire that uses a seven-point Likert scale to score responses. The scale ranges from 1, which means "strongly disagree," to 7, which means "strongly agree". The minimum score is 9 and the maximum score is 63. A higher score indicates more severe fatigue.
Measured: up to day 10
Patient Health Questionnaire-Depression
The Patient Health Questionnaire-8 (PHQ-8) is a self-reported scale that measures depressive symptoms over the previous two weeks. The PHQ-8 is scored by adding up the scores for each of the eight items, which range from 0 to 3. The response options for each item are:
0: Not at all
- Several days
- More than half the days
- Nearly every day
The total score ranges from 0 to 24, with higher scores indicating more severe depressive symptoms. The PHQ-8's scoring categories are:
0-4: No significant depressive symptoms 5-9: Mild symptoms 10-14: Moderate symptoms 15-19: Moderately severe symptoms 20-24: Severe symptoms A score of 10 or higher is considered major depression, and a score of 20 or higher is considered severe major depression
Measured: baseline
Patient Health Questionnaire-Depression
The Patient Health Questionnaire-8 (PHQ-8) is a self-reported scale that measures depressive symptoms over the previous two weeks. The PHQ-8 is scored by adding up the scores for each of the eight items, which range from 0 to 3. The response options for each item are:
0: Not at all
- Several days
- More than half the days
- Nearly every day
The total score ranges from 0 to 24, with higher scores indicating more severe depressive symptoms. The PHQ-8's scoring categories are:
0-4: No significant depressive symptoms 5-9: Mild symptoms 10-14: Moderate symptoms 15-19: Moderately severe symptoms 20-24: Severe symptoms A score of 10 or higher is considered major depression, and a score of 20 or higher is considered severe major depression
Measured: up to day 10
Generalized Anxiety Disorder
The GAD-7 is a screening tool that measures the severity of anxiety. It's scored by assigning points to the response categories of "not at all", "several days", "more than half the days", and "nearly every day". The total score ranges from 0 to 21.
0-4: Minimal anxiety, no intervention required 5-9: Mild anxiety, monitoring and follow-up recommended 10-14: Moderate anxiety, education about symptoms and therapy services recommended 15-21: Severe anxiety, therapy and medication recommended
Measured: baseline
Generalized Anxiety Disorder
The GAD-7 is a screening tool that measures the severity of anxiety. It's scored by assigning points to the response categories of "not at all", "several days", "more than half the days", and "nearly every day". The total score ranges from 0 to 21.
0-4: Minimal anxiety, no intervention required 5-9: Mild anxiety, monitoring and follow-up recommended 10-14: Moderate anxiety, education about symptoms and therapy services recommended 15-21: Severe anxiety, therapy and medication recommended
Measured: up to day 10
EuroQOL (EQ-5D-5L)
An index value of 1 represents the best possible health state, while an index value of <0 (variable) represents the worst possible health state.
Measured: Baseline
EuroQOL (EQ-5D-5L)
An index value of 1 represents the best possible health state, while an index value of <0 (variable) represents the worst possible health state.
Measured: up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Nov 2024
- Primary completion21 Aug 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stiff-Person SyndromeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janus S Patel, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242678
- Sponsor's protocol ID
- IRB00098231
- Status last verified
- Jun 2025
- First submitted
- 24 Jan 2024
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: study results will be shared via publication
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Spinal Cord Stimulation for Stiff Person Syndrome
- ClinicalTrials.gov ID
- NCT06242678
- Acronym / sponsor ID
- IRB00098231
- Conditions
- Stiff-Person Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective pilot study is to gather preliminary evidence evaluating spinal cord stimulation (SCS) as a potential therapy for the treatment of rigidity and painful spasms in patients with stiff person syndrome (SPS), a rare autoimmune neurological condition. The hypothesis is that SCS-mediated clinical improvement occurs through multi-modal mechanisms of action targeting several components of neuronal inhibitory signaling pathways in the spinal cord.
Detailed description
The hypothesis is that SCS-mediated clinical improvement occurs through multi-modal mechanisms of action targeting several components of neuronal inhibitory signaling pathways in the spinal cord.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCS trial lead | Experimental | Device: SCS trial leadplacement of spinal cord stimulator trial leads |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is 18 years of age or older at the time that the Informed Consent Form (ICF) is signed.
- Has been clinically diagnosed with stiff person syndrome
- Has clinical symptoms of muscle rigidity and spasms in the truncal (including abdominal, thoracic paraspinal, and pectoral) or proximal lower limb musculature
- Has Cerebrospinal fluid (CSF) Anti-glutamic acid decarboxylase 65 (anti-GAD65) antibodies or serum anti-GAD65 antibodies present at any titer
- Is currently trying or has tried in the past at least two conventional therapies with insufficient symptomatic relief or intolerable side effects (such as nonsteroidal anti- inflammatory drugs, topical patches/creams/gels/ointments, physical therapy, acupuncture, bracing, assistive devices, and lifestyle modification).
Key exclusion criteria (20 listed)
- Is less than 18 years of age at the time at the time that the Informed Consent Form (ICF) is signed.
- Has a Body Mass Index (BMI) > 45.
- Has a history of spine surgery or is planning to receive a spinal injection or procedure while participating in the study, unless this procedure can be postponed until after study completion.
- Has radiological findings or evidence of moderate to severe central spinal canal stenosis or neuroforaminal stenosis at any thoracic level or laterality.
- Has radiological findings or evidence of moderate/severe central spinal canal stenosis at any cervical or lumbar level.
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 |
|---|---|---|
| SCS trial leadplacement of spinal cord stimulator trial leads to see if effective in the management of symptoms associated with stiff person syndrome | Device | SCS trial lead |
Primary outcome
Pain Scores
Time frame: Baseline
baseline pain will be measured on a 0-100 scale, with 100 being the worse level of pain, with improvement in pain level measured immediately prior to removal (kept in up to 10 days), with pain level reassessed at 14 days after trial leads removed to see if returned to baseline
Pain Scores
Time frame: Day 24
baseline pain will be measured on a 0-100 scale, with 100 being the worse level of pain, with improvement in pain level measured immediately prior to removal (kept in up to 10 days), with pain level reassessed at 14 days after trial leads removed to see if returned to baseline
Michigan Body Map
Time frame: baseline
The Michigan Body Map (MBM) is a self-report measure to assess body areas of chronic pain with each area of pain marked is scored 1 point. Scores range from 0 to 35, with higher scores indicating more widespread body pain - Maximum score is 35. Higher score denotes more painful areas. It identifies the exact location of the area of recurrent or persistent pain. This map allows for accurate assessment of localized pain and widespread body pain to individualize pain management and track pain progress.
Michigan Body Map
Time frame: up to day 10
The Michigan Body Map (MBM) is a self-report measure to assess body areas of chronic pain with each area of pain marked is scored 1 point. Scores range from 0 to 35, with higher scores indicating more widespread body pain - Maximum score is 35. Higher score denotes more painful areas. It allows a patient to identify the exact location of the area(s) of recurrent or persistent pain. This map allows for accurate assessment of localized pain and widespread body pain to individualize pain management and track pain progress.
Penn Spasm Frequency and Severity Scale
Time frame: Baseline
The first component is a 5 point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour". The second component is a 3 point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe"
Penn Spasm Frequency and Severity Scale
Time frame: up to day 10
The first component is a 5 point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour". The second component is a 3 point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe"
Pain Disability Index
Time frame: Baseline
The Pain Disability Index (PDI) is a self-report questionnaire that measures the impact of pain on a person's life. The PDI is scored on a scale of 0 to 70, with higher scores indicating a greater degree of disability: 0: No disability 10: Total disability The PDI is made up of seven items, each rated on a scale of 0 to 10: Family/home, Recreation, Social activity, Occupation, Sexual behavior, Self-care, and Life-support activity.
Pain Disability Index
Time frame: up to Day 10
The Pain Disability Index (PDI) is a self-report questionnaire that measures the impact of pain on a person's life. The PDI is scored on a scale of 0 to 70, with higher scores indicating a greater degree of disability: 0: No disability 10: Total disability The PDI is made up of seven items, each rated on a scale of 0 to 10: Family/home, Recreation, Social activity, Occupation, Sexual behavior, Self-care, and Life-support activity.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
The PSQI is used to evaluate the overall subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Seven components, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. Maximum score is 21, indicative of poor sleep quality. Higher scoring denotes more difficulty in sleep - The global Pittsburgh Sleep Quality Index (PSQI) score ranges from 0 to 21
Pittsburgh Sleep Quality Index (PSQI)
Time frame: up to Day 10
The PSQI is used to evaluate the overall subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Seven components, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. Maximum score is 21, indicative of poor sleep quality. Higher scoring denotes more difficulty in sleep - The global Pittsburgh Sleep Quality Index (PSQI) score ranges from 0 to 21
Fatigue Severity Scale (FSS) Scores
Time frame: baseline
The FSS is a nine-item questionnaire that uses a seven-point Likert scale to score responses. The scale ranges from 1, which means "strongly disagree," to 7, which means "strongly agree". The minimum score is 9 and the maximum score is 63. A higher score indicates more severe fatigue.
Fatigue Severity Scale (FSS) Scores
Time frame: up to day 10
The FSS is a nine-item questionnaire that uses a seven-point Likert scale to score responses. The scale ranges from 1, which means "strongly disagree," to 7, which means "strongly agree". The minimum score is 9 and the maximum score is 63. A higher score indicates more severe fatigue.
Patient Health Questionnaire-Depression
Time frame: baseline
The Patient Health Questionnaire-8 (PHQ-8) is a self-reported scale that measures depressive symptoms over the previous two weeks. The PHQ-8 is scored by adding up the scores for each of the eight items, which range from 0 to 3. The response options for each item are: 0: Not at all 1. Several days 2. More than half the days 3. Nearly every day The total score ranges from 0 to 24, with higher scores indicating more severe depressive symptoms. The PHQ-8's scoring categories are: 0-4: No significant depressive symptoms 5-9: Mild symptoms 10-14: Moderate symptoms 15-19: Moderately severe symptoms 20-24: Severe symptoms A score of 10 or higher is considered major depression, and a score of 20 or higher is considered severe major depression
Patient Health Questionnaire-Depression
Time frame: up to day 10
The Patient Health Questionnaire-8 (PHQ-8) is a self-reported scale that measures depressive symptoms over the previous two weeks. The PHQ-8 is scored by adding up the scores for each of the eight items, which range from 0 to 3. The response options for each item are: 0: Not at all 1. Several days 2. More than half the days 3. Nearly every day The total score ranges from 0 to 24, with higher scores indicating more severe depressive symptoms. The PHQ-8's scoring categories are: 0-4: No significant depressive symptoms 5-9: Mild symptoms 10-14: Moderate symptoms 15-19: Moderately severe symptoms 20-24: Severe symptoms A score of 10 or higher is considered major depression, and a score of 20 or higher is considered severe major depression
Generalized Anxiety Disorder
Time frame: baseline
The GAD-7 is a screening tool that measures the severity of anxiety. It's scored by assigning points to the response categories of "not at all", "several days", "more than half the days", and "nearly every day". The total score ranges from 0 to 21. 0-4: Minimal anxiety, no intervention required 5-9: Mild anxiety, monitoring and follow-up recommended 10-14: Moderate anxiety, education about symptoms and therapy services recommended 15-21: Severe anxiety, therapy and medication recommended
Generalized Anxiety Disorder
Time frame: up to day 10
The GAD-7 is a screening tool that measures the severity of anxiety. It's scored by assigning points to the response categories of "not at all", "several days", "more than half the days", and "nearly every day". The total score ranges from 0 to 21. 0-4: Minimal anxiety, no intervention required 5-9: Mild anxiety, monitoring and follow-up recommended 10-14: Moderate anxiety, education about symptoms and therapy services recommended 15-21: Severe anxiety, therapy and medication recommended
EuroQOL (EQ-5D-5L)
Time frame: Baseline
An index value of 1 represents the best possible health state, while an index value of <0 (variable) represents the worst possible health state.
EuroQOL (EQ-5D-5L)
Time frame: up to Day 10
An index value of 1 represents the best possible health state, while an index value of <0 (variable) represents the worst possible health state.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. study results will be shared via publication
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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.
Janus S Patel, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCS trial lead in people with Stiff-Person Syndrome, run by Wake Forest University Health Sciences 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 10 inclusion and 20 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: finished, as of the sponsor's last update on 31 Aug 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?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Scores (time frame: Baseline). The study lists 18 primary outcomes in all. 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 31 Aug 2026.