Chronic PainNCT03984201
Accelerated Theta Burst in Chronic Pain: A Biomarker Study
A study testing Intermittent Theta Burst Stimulation (iTBS) in people with Chronic Pain, run by Stanford University at 1 site in United States.
Trial summary
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for chronic pain. In this double blind, randomized control study, participants will be randomized to the treatment group to receive accelerated theta-burst stimulation or to a control group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Intermittent Theta Burst Stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients need to meet at least a 4/10 on a clinical pain rating scale and/or fulfill fibromyalgia diagnostic criteria on the 2010 Fibromyalgia Diagnostic Criteria (Wolfe et al., 2010)
- Age 18 - 70
- Right-handed
- Agree to having fMRI scans as well as rTMS sessions
- Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and treatment
- Women of childbearing potential must agree to use adequate contraception prior to study entry and continue this for the duration of the study
- Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. Antidepressant must be of the SSRI class only (if currently on a different antidepressant, patients will be switched to an SSRI). They must maintain that same antidepressant regimen throughout the study duration.
Who cannot join
- History of MI, CABG, CHF, or other cardiac history.
- Any condition that would contraindicate MRI (such as ferromagnetic metal in the body)
- Pregnancy or breastfeeding
- Any neurological condition, history of epilepsy, history of rTMS failure with FDA approved rTMS parameters, history of any implanted device or psychosurgery for depression, history of receiving ECT. OCD, narcolepsy or any additional significant neurological disorder as determined by the PI.
- Autism spectrum disorder
- Inability to stop taking medication contraindicated with treatment
- Any significant psychiatric disorder as identified on the Mini International Neuropsychiatric Interview and determined by the PI
- A positive urine toxicology screen
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for chronic pain. In this double blind, randomized control study, participants will be randomized to the treatment group to receive accelerated theta-burst stimulation or to a control group. All participants will be offered the open-label, active treatment 4 week prior to completing the initial 5 days of treatment.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression and has been utilized to treat persons suffering from chronic pain. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
- Conditions
- Chronic Pain
- Being tested
- Intermittent Theta Burst Stimulation (iTBS)
- Keywords
- Chronic Pain, Repetitive Transcranial Magnetic Stimulation (rTMS), Accelerated Theta Burst Stimulation (aTBS), Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst Stimulation (iTBS)Device
Also called Accelerated Theta Burst Stimulation (aTBS), Repetitive Transcranial Magnetic Stimulation (rTMS)
Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.
| Study group | Role | What they receive |
|---|---|---|
| iTBS over L-DLPFC to dACC | Active comparator | Participants will receive iTBS (intermittent theta burst stimulation) to the left dorsal lateral prefrontal cortex (L-DLPFC) with high connectivity to the dorsal anterior cingulate cortex (dACC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
Stimulation will be delivered to L-DLPFC using the MagPRo stimulator. Receives: Device: Intermittent Theta Burst Stimulation (iTBS) |
| iTBS over L-DLPFC to sgACC | Active comparator | Participants will receive iTBS (intermittent theta burst stimulation) to the left dorsal lateral prefrontal cortex (L-DLPFC) with high connectivity to the subgenual cingulate cortex (sgACC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
Stimulation will be delivered to L-DLPFC using the MagPRo stimulator. Receives: Device: Intermittent Theta Burst Stimulation (iTBS) |
| Sham iTBS over L-DLPFC | Sham comparator | Participants will receive sham iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system.
Sham stimulation will be delivered to L-DLPFC using the MagPRo stimulator. Receives: Device: Intermittent Theta Burst Stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Brief Pain Inventory (BPI) score
A self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of depression and individual is experiencing.
Scoring:
- Pain Severity Score: This is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10.
- Pain Interference Score: This is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.
Measured: Pre-treatment, immediately post-treatment
Change in the McGill Pain Questionnaire score
A self-report questionnaire that allows individuals that assesses the quality and intensity of pain that is experienced. The pain rating index has 2 subscales: sensory subscale with 11 words, and affective subscale with 4 words. These items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10cm visual analogue scale for average pain.
Measured: Pre-treatment, immediately post-treatment
Secondary outcomes (4)
Change in the Montgomery Asberg Depression Rating Scale (MADRS) score
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60; 0 to 6 - normal, symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression.
Measured: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment
Change in teh Hamilton Rating Scale for Depression (HAM-17) score
A provider administered questionnaire used to assess remission and recovery from depression. in general the higher the total score the more severe the depression. HAM-D score level of depression: 10-13 mild; 14-17 mild to moderate; >17 moderate to severe.
Measured: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment
Change in the Pain Catastrophizing Scale (PCS) score
A self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52 that measures a person's catastrophizing of pain. A higher score indicates a higher level of pain catastrophizing.
Measured: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment
Change in functional connectivity as measured by Functional Magnetic Resonance Imaging (fMRI)
Participants will have fMRI scans both before the first treatment (baseline) and after the aiTBS course. The MRI scans will be used to identify potential biomarkers for antidepressant response and pain response, as well as identify aiTBS-induced changes in functional connectivity.
Measured: Pre-treatment, immediately post-treatment, 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Jun 2023 (estimated)
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Why it stopped: The site was unable to recruit participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Blinded, randomized control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nolan R, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984201
- Sponsor's protocol ID
- 48366
- Status last verified
- Dec 2024
- First submitted
- 30 May 2019
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Avery DH, Zarkowski P, Krashin D, Rho WK, Wajdik C, Joesch JM, Haynor DR, Buchwald D, Roy-Byrne P. Transcranial magnetic stimulation in the treatment of chronic widespread pain: a randomized controlled study. J ECT. 2015 Mar;31(1):57-66. doi: 10.1097/YCT.0000000000000125.
PubMed 24755729Baeken C, Marinazzo D, Everaert H, Wu GR, Van Hove C, Audenaert K, Goethals I, De Vos F, Peremans K, De Raedt R. The Impact of Accelerated HF-rTMS on the Subgenual Anterior Cingulate Cortex in Refractory Unipolar Major Depression: Insights From 18FDG PET Brain Imaging. Brain Stimul. 2015 Jul-Aug;8(4):808-15. doi: 10.1016/j.brs.2015.01.415. Epub 2015 Feb 7.
PubMed 25744500Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
PubMed 29726344Bonelli RM, Cummings JL. Frontal-subcortical circuitry and behavior. Dialogues Clin Neurosci. 2007;9(2):141-51. doi: 10.31887/DCNS.2007.9.2/rbonelli.
PubMed 17726913Borckardt JJ, Nahas Z, Koola J, George MS. Estimating resting motor thresholds in transcranial magnetic stimulation research and practice: a computer simulation evaluation of best methods. J ECT. 2006 Sep;22(3):169-75. doi: 10.1097/01.yct.0000235923.52741.72.
PubMed 16957531Cieslik EC, Zilles K, Caspers S, Roski C, Kellermann TS, Jakobs O, Langner R, Laird AR, Fox PT, Eickhoff SB. Is there "one" DLPFC in cognitive action control? Evidence for heterogeneity from co-activation-based parcellation. Cereb Cortex. 2013 Nov;23(11):2677-89. doi: 10.1093/cercor/bhs256. Epub 2012 Aug 23.
PubMed 22918987Connolly KR, Helmer A, Cristancho MA, Cristancho P, O'Reardon JP. Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. J Clin Psychiatry. 2012 Apr;73(4):e567-73. doi: 10.4088/JCP.11m07413.
PubMed 22579164Duprat R, Desmyter S, Rudi de R, van Heeringen K, Van den Abbeele D, Tandt H, Bakic J, Pourtois G, Dedoncker J, Vervaet M, Van Autreve S, Lemmens GM, Baeken C. Accelerated intermittent theta burst stimulation treatment in medication-resistant major depression: A fast road to remission? J Affect Disord. 2016 Aug;200:6-14. doi: 10.1016/j.jad.2016.04.015. Epub 2016 Apr 19.
PubMed 27107779Gamboa OL, Antal A, Moliadze V, Paulus W. Simply longer is not better: reversal of theta burst after-effect with prolonged stimulation. Exp Brain Res. 2010 Jul;204(2):181-7. doi: 10.1007/s00221-010-2293-4. Epub 2010 Jun 22.
PubMed 20567808George MS, Ketter TA, Parekh PI, Rosinsky N, Ring H, Casey BJ, Trimble MR, Horwitz B, Herscovitch P, Post RM. Regional brain activity when selecting a response despite interference: An H2 (15) O PET study of the stroop and an emotional stroop. Hum Brain Mapp. 1994;1(3):194-209. doi: 10.1002/hbm.460010305.
PubMed 24578040George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
PubMed 20439832George MS, Taylor JJ, Short EB. The expanding evidence base for rTMS treatment of depression. Curr Opin Psychiatry. 2013 Jan;26(1):13-8. doi: 10.1097/YCO.0b013e32835ab46d.
PubMed 23154644Grimm S, Beck J, Schuepbach D, Hell D, Boesiger P, Bermpohl F, Niehaus L, Boeker H, Northoff G. Imbalance between left and right dorsolateral prefrontal cortex in major depression is linked to negative emotional judgment: an fMRI study in severe major depressive disorder. Biol Psychiatry. 2008 Feb 15;63(4):369-76. doi: 10.1016/j.biopsych.2007.05.033. Epub 2007 Sep 21.
PubMed 17888408Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
PubMed 15664172Kreuzer PM, Schecklmann M, Lehner A, Wetter TC, Poeppl TB, Rupprecht R, de Ridder D, Landgrebe M, Langguth B. The ACDC pilot trial: targeting the anterior cingulate by double cone coil rTMS for the treatment of depression. Brain Stimul. 2015 Mar-Apr;8(2):240-6. doi: 10.1016/j.brs.2014.11.014. Epub 2014 Nov 29.
PubMed 25541389
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Theta Burst in Chronic Pain: A Biomarker Study
- ClinicalTrials.gov ID
- NCT03984201
- Acronym / sponsor ID
- 48366
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Repetitive Transcranial Magnetic Stimulation (rTMS), Accelerated Theta Burst Stimulation (aTBS), Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The site was unable to recruit participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 12 Jun 2019 (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.
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for chronic pain. In this double blind, randomized control study, participants will be randomized to the treatment group to receive accelerated theta-burst stimulation or to a control group. All participants will be offered the open-label, active treatment 4 week prior to completing the initial 5 days of treatment.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression and has been utilized to treat persons suffering from chronic pain. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Blinded, randomized control
| Arm | Type | Receives |
|---|---|---|
| iTBS over L-DLPFC to dACC | Active comparator | Device: Intermittent Theta Burst Stimulation (iTBS)Participants will receive iTBS (intermittent theta burst stimulation) to the left dorsal lateral prefrontal cortex (L-DLPFC) with high connectivity to the dorsal anterior cingulate cortex (dACC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to L-DLPFC using the MagPRo stimulator. |
| iTBS over L-DLPFC to sgACC | Active comparator | Device: Intermittent Theta Burst Stimulation (iTBS)Participants will receive iTBS (intermittent theta burst stimulation) to the left dorsal lateral prefrontal cortex (L-DLPFC) with high connectivity to the subgenual cingulate cortex (sgACC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to L-DLPFC using the MagPRo stimulator. |
| Sham iTBS over L-DLPFC | Sham comparator | Device: Intermittent Theta Burst Stimulation (iTBS)Participants will receive sham iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Sham stimulation will be delivered to L-DLPFC using the MagPRo stimulator. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients need to meet at least a 4/10 on a clinical pain rating scale and/or fulfill fibromyalgia diagnostic criteria on the 2010 Fibromyalgia Diagnostic Criteria (Wolfe et al., 2010)
- Age 18 - 70
- Right-handed
- Agree to having fMRI scans as well as rTMS sessions
- Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and treatment
Key exclusion criteria (8 listed)
- History of MI, CABG, CHF, or other cardiac history.
- Any condition that would contraindicate MRI (such as ferromagnetic metal in the body)
- Pregnancy or breastfeeding
- Any neurological condition, history of epilepsy, history of rTMS failure with FDA approved rTMS parameters, history of any implanted device or psychosurgery for depression, history of receiving ECT. OCD, narcolepsy or any additional significant neurological disorder as determined by the PI.
- Autism spectrum disorder
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 |
|---|---|---|
| Intermittent Theta Burst Stimulation (iTBS)Also: Accelerated Theta Burst Stimulation (aTBS), Repetitive Transcranial Magnetic Stimulation (rTMS)Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC. | Device | Sham iTBS over L-DLPFC, iTBS over L-DLPFC to dACC, iTBS over L-DLPFC to sgACC |
Primary outcome
Change in the Brief Pain Inventory (BPI) score
Time frame: Pre-treatment, immediately post-treatment
A self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of depression and individual is experiencing. Scoring: 1. Pain Severity Score: This is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10. 2. Pain Interference Score: This is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.
Change in the McGill Pain Questionnaire score
Time frame: Pre-treatment, immediately post-treatment
A self-report questionnaire that allows individuals that assesses the quality and intensity of pain that is experienced. The pain rating index has 2 subscales: sensory subscale with 11 words, and affective subscale with 4 words. These items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10cm visual analogue scale for average pain.
4 secondary outcomes
Change in the Montgomery Asberg Depression Rating Scale (MADRS) score
Time frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment
Change in teh Hamilton Rating Scale for Depression (HAM-17) score
Time frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment
Change in the Pain Catastrophizing Scale (PCS) score
Time frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment
Change in functional connectivity as measured by Functional Magnetic Resonance Imaging (fMRI)
Time frame: Pre-treatment, immediately post-treatment, 4 weeks post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Background: PubMed 24755729Avery DH, Zarkowski P, Krashin D, Rho WK, Wajdik C, Joesch JM, Haynor DR, Buchwald D, Roy-Byrne P. Transcranial magnetic stimulation in the treatment of chronic widespread pain: a randomized controlled study. J ECT. 2015 Mar;31(1):57-66. doi: 10.1097/YCT.0000000000000125.
- Background: PubMed 25744500Baeken C, Marinazzo D, Everaert H, Wu GR, Van Hove C, Audenaert K, Goethals I, De Vos F, Peremans K, De Raedt R. The Impact of Accelerated HF-rTMS on the Subgenual Anterior Cingulate Cortex in Refractory Unipolar Major Depression: Insights From 18FDG PET Brain Imaging. Brain Stimul. 2015 Jul-Aug;8(4):808-15. doi: 10.1016/j.brs.2015.01.415. Epub 2015 Feb 7.
- Background: PubMed 29726344Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
- Background: PubMed 17726913Bonelli RM, Cummings JL. Frontal-subcortical circuitry and behavior. Dialogues Clin Neurosci. 2007;9(2):141-51. doi: 10.31887/DCNS.2007.9.2/rbonelli.
- Background: PubMed 16957531Borckardt JJ, Nahas Z, Koola J, George MS. Estimating resting motor thresholds in transcranial magnetic stimulation research and practice: a computer simulation evaluation of best methods. J ECT. 2006 Sep;22(3):169-75. doi: 10.1097/01.yct.0000235923.52741.72.
- Background: PubMed 22918987Cieslik EC, Zilles K, Caspers S, Roski C, Kellermann TS, Jakobs O, Langner R, Laird AR, Fox PT, Eickhoff SB. Is there "one" DLPFC in cognitive action control? Evidence for heterogeneity from co-activation-based parcellation. Cereb Cortex. 2013 Nov;23(11):2677-89. doi: 10.1093/cercor/bhs256. Epub 2012 Aug 23.
- Background: PubMed 22579164Connolly KR, Helmer A, Cristancho MA, Cristancho P, O'Reardon JP. Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. J Clin Psychiatry. 2012 Apr;73(4):e567-73. doi: 10.4088/JCP.11m07413.
- Background: PubMed 27107779Duprat R, Desmyter S, Rudi de R, van Heeringen K, Van den Abbeele D, Tandt H, Bakic J, Pourtois G, Dedoncker J, Vervaet M, Van Autreve S, Lemmens GM, Baeken C. Accelerated intermittent theta burst stimulation treatment in medication-resistant major depression: A fast road to remission? J Affect Disord. 2016 Aug;200:6-14. doi: 10.1016/j.jad.2016.04.015. Epub 2016 Apr 19.
- Background: PubMed 20567808Gamboa OL, Antal A, Moliadze V, Paulus W. Simply longer is not better: reversal of theta burst after-effect with prolonged stimulation. Exp Brain Res. 2010 Jul;204(2):181-7. doi: 10.1007/s00221-010-2293-4. Epub 2010 Jun 22.
- Background: PubMed 24578040George MS, Ketter TA, Parekh PI, Rosinsky N, Ring H, Casey BJ, Trimble MR, Horwitz B, Herscovitch P, Post RM. Regional brain activity when selecting a response despite interference: An H2 (15) O PET study of the stroop and an emotional stroop. Hum Brain Mapp. 1994;1(3):194-209. doi: 10.1002/hbm.460010305.
- Background: PubMed 20439832George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
- Background: PubMed 23154644George MS, Taylor JJ, Short EB. The expanding evidence base for rTMS treatment of depression. Curr Opin Psychiatry. 2013 Jan;26(1):13-8. doi: 10.1097/YCO.0b013e32835ab46d.
- 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. 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 Intermittent Theta Burst Stimulation (iTBS) in people with Chronic Pain, run by Stanford 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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 20 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in the Brief Pain Inventory (BPI) score (time frame: Pre-treatment, immediately post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03984201, which also lists 31 linked publications.
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 20 Dec 2024.