Neuromodulation to Facilitate the Effect of Ketamine | NCT01816958

Studies
Neuromodulation to Facilitate the Effect of Ketamine

NCT01816958

Sponsor

The Neuroscience Center, LLC

Status

Completed

Last Update Posted

Mar 22, 2013Estimated

Enrollment

35Actual

Phase

Not provided

Conditions

Depression
Chronic Pain
Substance Abuse

Interventions

co-administration of TMS and infused ketamine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Mar 11, 2013

First Submission Date that Met QC Criteria

Mar 20, 2013

First Posted Date

Mar 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2013

Last Update Posted Date

Mar 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chronic depression and/or pain		co-administration of TMS and infused ketamine for patients with chronic pain of psyche and/or soma	Other: co-administration of TMS and infused ketamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
co-administration of TMS and infused ketamine	Other	co-administration of TMS and infused ketamine	chronic depression and/or pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global Assessment of Function in DSM-4R	treat in order to cause remission of disability	up to 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronically ill,
treatment-resistant

Exclusion Criteria:

active psychosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients within my own clinic, suffering with chronic emotional and/or somatic pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven R Devore Best, M.D.	The Neuroscience Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Neuroscience Center		Deerfield	Illinois	60015	United States

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D059350	Chronic Pain
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D010146	Pain
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided