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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50DA044121 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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In this study the investigators aim to examine the effects of Transcranial Magnetic Stimulation (TMS) on hippocampal network connectivity and pain levels in individuals with chronic low back pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hippocampus-stimulation | Experimental | Active high-frequency rTMS (20 Hz pulse trains) |
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| Sham-stimulation | Experimental | Sham rTMS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | For the brain stimulation the investigators will use Repetitive Transcranial Magnetic stimulation (rTMS). Different stimulation conditions (hippocampal or sham) will be delivered in each round of stimulation (5 days). Repetitive TMS will be applied at 100% resting motor threshold intensity, 20 Hz pulse trains separated by 28-s inter-train intervals (~20 minutes for the entire daily stimulation session). Stimulation parameters will be identical in both groups |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pain Scales | The endpoint will be the severity of pain measured by changes in the Numeric Rating Scale (NRS) scores before and after each stimulation round. The NRS is a pain screening tool that assesses pain severity during assessment using a 0-10 scale, where zero means "no pain" and ten means "the worst pain imaginable." Higher values indicate a worse outcome. | Pain is assessed at baseline, end of first intervention and end of the second intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hippocampal Connectivity | Changes in hippocampal network connectivity will be evaluated by using resting state functional magnetic resonance (fMRI) before and after hippocampal stimulation. Hippocampal connectivity measurements - regions involved in the network and the parietal target - will be compared before stimulation (baseline) to after stimulation (after active hippocampal stimulation). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
Documents will be provided by Apkar Apkarian
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Of the 44 participants screened, 16 met inclusion criteria and were randomized to treatment.
Participants were screened via a database maintained by one of the co-investigators. The first participant was enrolled on June 25, 2021, and the last participant was enrolled in February 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hippocampus-stimulation First Then Sham-stimulation | Over five consecutive days, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which is determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals. Each daily stimulation session lasts about 20 minutes. After a two-week washout period, we administer sham stimulation with identical parameters except that the coil is flipped over to the sham side, and a stimulating electrode is attached to the skin near the parietal rTMS target location. This electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to discriminate between the two types of stimulation. |
| FG001 | Sham-stimulation First Then Hippocampus-stimulation | For five consecutive days, we administer sham stimulation by flipping the coil over to the sham side and attaching a stimulating electrode to the skin near the parietal rTMS target location. The electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to distinguish between the two types of stimulation. Each daily stimulation session lasts around 20 minutes. After a two-week washout period, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which will be determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hippocampus-stimulation First, Then Sham-stimulation | Over five consecutive days, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which is determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals. Each daily stimulation session lasts about 20 minutes. After a two-week washout period, we administer sham stimulation with identical parameters except that the coil is flipped over to the sham side, and a stimulating electrode is attached to the skin near the parietal rTMS target location. This electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to discriminate between the two types of stimulation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Pain Scales | The endpoint will be the severity of pain measured by changes in the Numeric Rating Scale (NRS) scores before and after each stimulation round. The NRS is a pain screening tool that assesses pain severity during assessment using a 0-10 scale, where zero means "no pain" and ten means "the worst pain imaginable." Higher values indicate a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | Pain is assessed at baseline, end of first intervention and end of the second intervention. |
|
Adverse events were assessed every visit (protocol) through study completion, an average of seven weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hippocampus-stimulation | Different stimulation conditions (hippocampal or sham) will be delivered in each round of stimulation (5 days). Repetitive TMS will be applied at 100% resting motor threshold intensity to a region of interest located in the parietal cortex, which will be determined based on its connectivity with the hippocampus. This stimulation consists of a series of 1,600 pulses administered as 2-second periods of 20 Hz pulse trains separated by 28-s inter-train intervals (~20 minutes for the entire daily stimulation session). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A. Vania Apkarian | Northwestern University | +1 312 503 0404 | a-apkarian@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2021 | Feb 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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All participants will receive the 2 modalities of stimulation (hippocampal and sham-TMS). Each stimulation round is composed by 5 daily sessions of stimulation, participants will not know which round is active and which is sham. The order of the stimulation modalities will be different across subjects. Subjects will be randomly assigned to one of two possible modality order according to the entrance in the study.
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| Sham rTMS | Device | Sham rTMS |
|
| approximately 6 weeks - Baseline and after the end of hippocampal stimulation |
| BG001 | Sham-stimulation Then Hippocampus Stimulation | For five consecutive days, we administer sham stimulation by flipping the coil over to the sham side and attaching a stimulating electrode to the skin near the parietal rTMS target location. The electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to distinguish between the two types of stimulation. Each daily stimulation session lasts around 20 minutes. After a two-week washout period, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which will be determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Pain | The severity of baseline pain is measured with the Numeric Rating Scale (NRS) scores. The NRS is a pain screening tool that assesses pain severity during assessment using a 0-10 scale, where zero means "no pain" and ten means "the worst pain imaginable." | Mean | Standard Deviation | units on a scale |
|
| OG001 | Sham-stimulation | For five consecutive days, we administer sham stimulation by flipping the coil over to the sham side and attaching a stimulating electrode to the skin near the parietal rTMS target location. The electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to distinguish between the two types of stimulation. Each daily stimulation session lasts around 20 minutes. |
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| Secondary | Changes in Hippocampal Connectivity | Changes in hippocampal network connectivity will be evaluated by using resting state functional magnetic resonance (fMRI) before and after hippocampal stimulation. Hippocampal connectivity measurements - regions involved in the network and the parietal target - will be compared before stimulation (baseline) to after stimulation (after active hippocampal stimulation). | The data was not collected due to the COVID-19 pandemic. | Posted | approximately 6 weeks - Baseline and after the end of hippocampal stimulation |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Sham-stimulation | Parameters will be identical to the hippocampus-stimulation, except that the coil will be flipped over to the sham side, and a stimulating electrode will be attached to the skin near the parietal rTMS target location. This electrode will be used to deliver a small current mimicking real stimulation sensation; therefore, participants cannot reliably discriminate physical sensations for real versus sham rTMS. | 0 | 10 | 0 | 10 | 0 | 10 |
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