Chronic PainNCT04888494
Hippocampal Stimulation in Chronic Low Back Pain
A study testing Transcranial Magnetic Stimulation in people with Chronic Pain and Back Pain, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Back Pain, Pain
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2021to 2 Feb 2023
- 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
- ≥ 6 months of back pain on a daily basis;
- male or female with no racial or ethnic restrictions;
- 18 to 75 years old;
- average back pain intensity > 4/10 at study entry;
- must be able to read, understand, and sign consent form;
- generally healthy.
Who cannot join
- back pain with fever, chills, rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
- history of tumor in the back;
- back surgery within the past 6 months;
- Chronic neurologic conditions, e.g., Parkinson's
- involvement in litigation regarding back pain;
- other severe medical diseases;
Show all 17Show fewer
- pregnancy;
- positive urinary screen for any recreational drugs,
- opioids use;
- use of anticoagulants (low dose ASA allowed);
- history of gastric ulcer; renal insufficiency or congestive heart failure,
- contraindication to MRI,
- contraindication to TMS; including history of seizure/epilepsy*
- Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
- In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
- Diagnosis of major depression;
- Intra-axial implants (e.g. spinal cord stimulators or pumps)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Enhancing Cortical-hippocampal Functional Connectivity as a Novel Means for Relieving Chronic Low Back Pain
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.
- Conditions
- Chronic Pain, Back Pain, Pain
- Being tested
- Transcranial Magnetic Stimulation, Sham rTMS
- Keywords
- transcranial magnetic stimulation, resting state MRI
- Medical subject headings
- Chronic Pain, Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
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
Sham rTMSDevice
Sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| Hippocampus-stimulation | Experimental | Active high-frequency rTMS (20 Hz pulse trains) Receives: Device: Transcranial Magnetic Stimulation |
| Sham-stimulation | Experimental | Sham rTMS Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pain is assessed at baseline, end of first intervention and end of the second intervention.
Secondary outcomes (1)
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).
Measured: approximately 6 weeks - Baseline and after the end of hippocampal stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start25 Jun 2021
- Primary completion1 Jun 2022
- Study completion2 Feb 2023
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 Chronic PainStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Apkar Apkarian, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888494
- Sponsor's protocol ID
- STU00211858
- Other IDs
- 5P50DA044121
- Status last verified
- May 2023
- First submitted
- 12 May 2021
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Documents will be provided by Apkar Apkarian
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cortical-hippocampal Functional Connectivity as a Novel Means for Relieving Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04888494
- Acronym / sponsor ID
- STU00211858
- Conditions
- Chronic Pain, Back Pain, Pain
- Keywords
- transcranial magnetic stimulation, resting state MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hippocampus-stimulation | Experimental | Device: Transcranial Magnetic StimulationActive high-frequency rTMS (20 Hz pulse trains) |
| Sham-stimulation | Experimental | Device: Sham rTMSSham rTMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 6 months of back pain on a daily basis;
- male or female with no racial or ethnic restrictions;
- 18 to 75 years old;
- average back pain intensity > 4/10 at study entry;
- must be able to read, understand, and sign consent form;
Key exclusion criteria (17 listed)
- back pain with fever, chills, rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
- history of tumor in the back;
- back surgery within the past 6 months;
- Chronic neurologic conditions, e.g., Parkinson's
- involvement in litigation regarding back pain;
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 Magnetic StimulationFor 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 | Device | Hippocampus-stimulation |
| Sham rTMSSham rTMS | Device | Sham-stimulation |
Primary outcome
Changes in Pain Scales
Time frame: Pain is assessed at baseline, end of first intervention and end of the second intervention.
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.
1 secondary outcome
Changes in Hippocampal Connectivity
Time frame: approximately 6 weeks - Baseline and after the end of hippocampal stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Documents will be provided by Apkar Apkarian
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Magnetic Stimulation in people with Chronic Pain and Back Pain, run by Northwestern 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 6 inclusion and 17 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 15 Jun 2023. 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 15 Jun 2023). 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?
Changes in Pain Scales (time frame: Pain is assessed at baseline, end of first intervention and end of the second intervention.). 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 15 Jun 2023; AzTrials last refreshed its copy on 31 Oct 2026.