Trial Outcomes & Findings for Evaluating Spinal Cord Stimulation for Stiff Person Syndrome (NCT NCT06242678)

Evaluating Spinal Cord Stimulation for Stiff Person Syndrome

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

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

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.

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.

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"

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"

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.

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.

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

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

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.

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.

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

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

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

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

An index value of 1 represents the best possible health state, while an index value of \<0 (variable) represents the worst possible health state.

An index value of 1 represents the best possible health state, while an index value of \<0 (variable) represents the worst possible health state.