Study Stopped
Unable to adequately recruit subjects.
Treatment of Negative Symptoms of Schizophrenia With Transcranial Magnetic Stimulation (TMS)
Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms and Social Dysfunction in Schizophrenia Patients
1 other identifier
interventional
14
1 country
1
Brief Summary
This study will test whether repetitive transcranial magnetic stimulation (rTMS) is helpful in treating negative symptoms and social deficits of schizophrenia. This will be the first rTMS study to assess social function and social cognition.
- 1.Hypoactivity in the dorsolateral prefrontal cortex (DLPFC) has been implicated in generating the negative symptoms of schizophrenia. Abnormalities in the left inferior parietal lobe (IPL) have also been associated with negative symptoms. We hypothesize that high frequency rTMS applied to the hypoactive left DLPFC or to the left IPL in individuals with schizophrenia will reduce negative symptom severity more than sham (placebo) rTMS as assessed by the Positive and Negative Syndrome Scale (PANSS) negative symptoms subscale.
- 2.We hypothesize that high frequency rTMS applied to the left DLPFC or to the left IPL in schizophrenia patients will improve social dysfunction more than sham (placebo) rTMS as assessed by the Social Adjustment Scale, the Social Adaptation Self-Evaluation Scale and the Social Functioning Scale.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 schizophrenia
Started Sep 2004
Longer than P75 for phase_2 schizophrenia
1 active site
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
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 14, 2007
CompletedFirst Posted
Study publicly available on registry
August 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
January 13, 2017
CompletedJanuary 13, 2017
January 1, 2017
6.8 years
August 14, 2007
January 12, 2017
January 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Improvement of Negative Symptoms (Positive and Negative Syndrome Scale [PANSS] Negative Symptoms Subscale) Relative to Pre-treatment Baseline.
At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.
Secondary Outcomes (7)
Global Clinical Improvement
At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.
Social Functioning
At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.
Depression
At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.
Theory of Mind
At baseline and the end of each study phase (random and open)
Smoking Behaviors
At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.
- +2 more secondary outcomes
Study Arms (4)
A
EXPERIMENTALhigh frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
B
ACTIVE COMPARATORActive high frequency rTMS to the left dorsolateral prefrontal cortex
C
SHAM COMPARATORSham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind
Open cross over high frequency rTMS
EXPERIMENTALFollowing the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --\> open phase DLPFC and vice versa)
Interventions
For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same.
For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same.
Eligibility Criteria
You may qualify if:
- Male or female inpatients or outpatients, 18 to 55 years of age.
- Primary diagnosis by DSM-IV criteria for Schizophrenia or Schizoaffective Disorder.
- Capacity and willingness to give informed consent.
- Engaged in ongoing treatment with a psychiatrist.
- PANSS negative symptoms subscale score of ≥ 15.
- English speaking.
- Patients must have stable symptoms as defined by not requiring a change in antipsychotic medication for at least 4 weeks or at least 2 weeks for other psychotropic agents (e.g. antidepressants) prior to entering the study. Patients will not be included in the study if the research team thinks that modifications could be made to maximize their medication regimen at initial evaluation.
- Able to adhere to the treatment schedule.
- Able to commute to NYC for daily treatments (Monday - Friday) for at least 4 weeks.
You may not qualify if:
- Individuals diagnosed by the investigator with the following conditions (current unless otherwise stated): Current affective disorder including Major Depressive Disorder, Bipolar Affective Disorder; substance abuse or dependence within the past year (except nicotine and caffeine).
- An Axis II Personality Disorder, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol.
- Individuals with a clinically defined neurological disorder or insult including, but not limited to: Any condition likely to be associated with increased intracranial pressure; Space occupying brain lesion; Any history of seizure EXCEPT those therapeutically induced by ECT; History of cerebrovascular accident; Transient ischemic attack within two years; Cerebral aneurysm; Dementia; Parkinson's disease; Huntington's chorea; or Multiple sclerosis.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), history of epilepsy or seizure in first-degree relatives, having metal inside the head, or history of significant head trauma with loss of consciousness for 5 minutes.
- Prior adverse reaction to TMS.
- History of treatment with rTMS therapy for any disorder.
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
- Current illicit drug use.
- Known or suspected pregnancy.
- Women who are breast-feeding.
- Women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse.
- Wearing medicinal skin patches during the MRI scan.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (3)
Hajak G, Marienhagen J, Langguth B, Werner S, Binder H, Eichhammer P. High-frequency repetitive transcranial magnetic stimulation in schizophrenia: a combined treatment and neuroimaging study. Psychol Med. 2004 Oct;34(7):1157-63. doi: 10.1017/s0033291704002338.
PMID: 15697042BACKGROUNDSachdev P, Loo C, Mitchell P, Malhi G. Transcranial magnetic stimulation for the deficit syndrome of schizophrenia: a pilot investigation. Psychiatry Clin Neurosci. 2005 Jun;59(3):354-7. doi: 10.1111/j.1440-1819.2005.01382.x.
PMID: 15896231BACKGROUNDJin Y, Potkin SG, Kemp AS, Huerta ST, Alva G, Thai TM, Carreon D, Bunney WE Jr. Therapeutic effects of individualized alpha frequency transcranial magnetic stimulation (alphaTMS) on the negative symptoms of schizophrenia. Schizophr Bull. 2006 Jul;32(3):556-61. doi: 10.1093/schbul/sbj020. Epub 2005 Oct 27.
PMID: 16254067BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Sherman
- Organization
- New York State Psychiatric Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Arielle D. Stanford, MD
New York State Psychiatric Institute / Columbia University College of Physicians and Surgeons
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2007
First Posted
August 16, 2007
Study Start
September 1, 2004
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
January 13, 2017
Results First Posted
January 13, 2017
Record last verified: 2017-01