DepressionTMS/ketamineNCT01816958
Neuromodulation to Facilitate the Effect of Ketamine
An observational study of Depression and Chronic Pain, run by The Neuroscience Center, LLC at 1 site in United States.
Trial summary
application of external neuromodulation along with ketamine infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Chronic Pain, Substance Abuse
- What is being tested?
- co-administration of TMS and infused ketamine
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients within my own clinic, suffering with chronic emotional and/or somatic pain
Who may be able to join
- chronically ill,
- treatment-resistant
Who cannot join
- active psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Thalamocortical Dysrhythmia Using External Neuromodulation to Facilitate the Therapeutic Effect of Ketamine.
application of external neuromodulation along with ketamine infusion.
Read the detailed description
apply TMS concurrent with ketamine infusion in order to increase the likliehood \& strength of therapeutic benefit
- Conditions
- Depression, Chronic Pain, Substance Abuse
- Being tested
- co-administration of TMS and infused ketamine
- Keywords
- thalamocortical dysrhythmia, transcranial magnetic stimulation (TMS), transcranial Electrical Stimulation (tES), (N-methyl-D-aspartate) NMDA-R antagonist, ketamine infusion, neuromodulation, synergistic effect, remission
- Medical subject headings
- Depression, Chronic Pain, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co-administration of TMS and infused ketamineOther
co-administration of TMS and infused ketamine
| Study group | Role | What they receive |
|---|---|---|
| chronic depression and/or pain | co-administration of TMS and infused ketamine for patients with chronic pain of psyche and/or soma Receives: Other: co-administration of TMS and infused ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment of Function in DSM-4R
treat in order to cause remission of disability
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Neuroscience Center, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Devore Best, M.D., Principal investigator, The Neuroscience Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816958
- Sponsor's protocol ID
- 12_1293
- Acronym
- TMS/ketamine
- Status last verified
- Mar 2013
- First submitted
- 11 Mar 2013
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Thalamocortical Dysrhythmia Using External Neuromodulation to Facilitate the Therapeutic Effect of Ketamine.
- ClinicalTrials.gov ID
- NCT01816958
- Acronym / sponsor ID
- TMS/ketamine / 12_1293
- Conditions
- Depression, Chronic Pain, Substance Abuse
- Keywords
- thalamocortical dysrhythmia, transcranial magnetic stimulation (TMS), transcranial Electrical Stimulation (tES), (N-methyl-D-aspartate) NMDA-R antagonist, ketamine infusion, neuromodulation, synergistic effect, remission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Neuroscience Center, LLCUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Mar 2013 (estimated)
- 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.
application of external neuromodulation along with ketamine infusion.
Detailed description
apply TMS concurrent with ketamine infusion in order to increase the likliehood \& strength of therapeutic benefit
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic depression and/or pain | – | Other: co-administration of TMS and infused ketamineco-administration of TMS and infused ketamine for patients with chronic pain of psyche and/or soma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients within my own clinic, suffering with chronic emotional and/or somatic pain
Key inclusion criteria (2 listed)
- chronically ill,
- treatment-resistant
Key exclusion criteria (1 listed)
- active psychosis
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 |
|---|---|---|
| co-administration of TMS and infused ketamineco-administration of TMS and infused ketamine | Other | chronic depression and/or pain |
Primary outcome
Global Assessment of Function in DSM-4R
Time frame: up to 3 years
treat in order to cause remission of disability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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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.
Steven R Devore Best, M.D. principal investigator
The Neuroscience Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Chronic Pain, run by The Neuroscience Center, LLC 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 2 inclusion and 1 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 22 Mar 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global Assessment of Function in DSM-4R (time frame: up to 3 years). 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 22 Mar 2013.