NCT02242578

Brief Summary

Symptomatic treatment of the negative symptoms in schizophrenia (such as social withdrawal, affective flattening, poor motivation, and apathy) with medications and psychotherapy are almost non-existent, whereas treatment of the positive symptoms (hallucinations and delusions) has been more effective with psychotropic medications. The proposed research on human subjects using a non-invasive technology (such as repetitive transcranial magnetic stimulation \[rTMS\]) will provide efficacy data for treating negative symptoms. The hypotheses are that 1) Cerebellar stimulation will cause activation of thalamic and frontal cortical networks associated with attentional processes as a component of the "distracted" affect of schizophrenia; 2) Cerebellar stimulation will cause activation of the reticular activating system (RAS), and this will allow the "mutism", which is a negative symptom, to be partially improved.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2011

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2018

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 12, 2021

Completed
Last Updated

April 12, 2021

Status Verified

March 1, 2021

Enrollment Period

7.4 years

First QC Date

September 12, 2014

Results QC Date

March 16, 2021

Last Update Submit

March 16, 2021

Conditions

Schizophrenia

Keywords

Negative symptoms

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 1 Week

    Participants will receive baseline and post-treatment protocol neuropsychiatric measures. These rating scales are accepted and standardized.

    Participants will be followed for an expected average of 5 weeks

Secondary Outcomes (1)

  • Change From Baseline in Electroencephalographic (EEG) Measures at 1 Week

    Participants will be followed for an expected average of 5 weeks

Study Arms (2)

Active

EXPERIMENTAL

Active rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)

Device: 1 Hz rTMSDevice: 10 Hz rTMS

Placebo

EXPERIMENTAL

Sham rTMS stimulation (1 Hz rTMS, 10 Hz rTMS)

Device: 1 Hz rTMSDevice: 10 Hz rTMS

Interventions

1 Hz rTMSDEVICE

About 1,000 stimulation pulses over 20 min

ActivePlacebo
10 Hz rTMSDEVICE

About 1,000 stimulation pulses over 20 min

ActivePlacebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients enrolling to the study:
  • must be stable on their medications at the start of their enrollment in the study and throughout the duration of the study;
  • must have no history of substance use of substance-dependence issues over at least the past six months;
  • must be able to and have the capacity to provide consent;
  • and if older patient, he/she must be able to participate without a safeguard to be present.

You may not qualify if:

  • Patients excluded from the study are:
  • Patients with typical clinical considerations that exclude them from treatment with TMS (i.e., patients who have had head injuries, patients with metal implants, patients with a history of seizures, patients with elevated risk of seizures, patients who are taking medications that may interfere with TMS or potentiate the related side effects, etc.).
  • Patients who have had changes in their medications (i.e., patients must be stable on their medications throughout their participation in the study).
  • Patients with history of substance abuse or substance-dependence anytime over the past six months.
  • Patients who are unable (i.e., do not have the capacity) to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seton Brain and Spine Institute "Brain Stimulation Laboratory"

Austin, Texas, 78701, United States

Location

Related Publications (7)

  • Andreasen NC, O'Leary DS, Cizadlo T, Arndt S, Rezai K, Ponto LL, Watkins GL, Hichwa RD. Schizophrenia and cognitive dysmetria: a positron-emission tomography study of dysfunctional prefrontal-thalamic-cerebellar circuitry. Proc Natl Acad Sci U S A. 1996 Sep 3;93(18):9985-90. doi: 10.1073/pnas.93.18.9985.

    PMID: 8790444BACKGROUND

  • Ende G, Hubrich P, Walter S, Weber-Fahr W, Kammerer N, Braus DF, Henn FA. Further evidence for altered cerebellar neuronal integrity in schizophrenia. Am J Psychiatry. 2005 Apr;162(4):790-2. doi: 10.1176/appi.ajp.162.4.790.

    PMID: 15800155BACKGROUND

  • Ho BC, Mola C, Andreasen NC. Cerebellar dysfunction in neuroleptic naive schizophrenia patients: clinical, cognitive, and neuroanatomic correlates of cerebellar neurologic signs. Biol Psychiatry. 2004 Jun 15;55(12):1146-53. doi: 10.1016/j.biopsych.2004.02.020.

    PMID: 15184033BACKGROUND

  • Nopoulos PC, Ceilley JW, Gailis EA, Andreasen NC. An MRI study of cerebellar vermis morphology in patients with schizophrenia: evidence in support of the cognitive dysmetria concept. Biol Psychiatry. 1999 Sep 1;46(5):703-11. doi: 10.1016/s0006-3223(99)00093-1.

    PMID: 10472423BACKGROUND

  • Picard H, Amado I, Mouchet-Mages S, Olie JP, Krebs MO. The role of the cerebellum in schizophrenia: an update of clinical, cognitive, and functional evidences. Schizophr Bull. 2008 Jan;34(1):155-72. doi: 10.1093/schbul/sbm049. Epub 2007 Jun 11.

    PMID: 17562694BACKGROUND

  • Rusch N, Spoletini I, Wilke M, Bria P, Di Paola M, Di Iulio F, Martinotti G, Caltagirone C, Spalletta G. Prefrontal-thalamic-cerebellar gray matter networks and executive functioning in schizophrenia. Schizophr Res. 2007 Jul;93(1-3):79-89. doi: 10.1016/j.schres.2007.01.029. Epub 2007 Mar 26.

    PMID: 17383859BACKGROUND

  • Rapoport M, van Reekum R, Mayberg H. The role of the cerebellum in cognition and behavior: a selective review. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):193-8. doi: 10.1176/jnp.12.2.193.

    PMID: 11001597BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Limitations and Caveats

Study was terminated and no data was collected.

Results Point of Contact

Title
Robert J Buchanan, MD
Organization
The University of Texas at Austin
robertbuchanan@utexas.edu
512-324-7991

Study Officials

  • Robert Buchanan, MD

    Seton Family Hopsitals

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Functional and Restorative Neurosurgery and Neurosciences

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 17, 2014

Study Start

January 24, 2011

Primary Completion

June 11, 2018

Study Completion

June 11, 2018

Last Updated

April 12, 2021

Results First Posted

April 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)