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Treatment of Negative Symptoms of Schizophrenia With Transcranial Magnetic Stimulation (TMS)

This study has been terminated.
(Unable to adequately recruit subjects.)
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00517075
First received: August 14, 2007
Last updated: January 12, 2017
Last verified: January 2017
Results First Received: January 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Device: Transcranial Magnetic Stimulation (TMS)
Device: repetitive transcranial magnetic stimulation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
High Frequency rTMS

high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind

Transcranial Magnetic Stimulation (TMS): 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.

Active High Frequency rTMS

Active high frequency rTMS to the left dorsolateral prefrontal cortex

Transcranial Magnetic Stimulation (TMS): 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.

Sham/Placebo

Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind

Transcranial Magnetic Stimulation (TMS): 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.

Open Cross Over High Frequency rTMS

Following 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)

repetitive transcranial magnetic stimulation: 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.


Participant Flow:   Overall Study
    High Frequency rTMS   Active High Frequency rTMS   Sham/Placebo   Open Cross Over High Frequency rTMS
STARTED   0   0   0   0 
COMPLETED   0   0   0   0 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.

Reporting Groups
  Description
High Frequency rTMS

high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind

Transcranial Magnetic Stimulation (TMS): 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.

Active High Frequency rTMS

Active high frequency rTMS to the left dorsolateral prefrontal cortex

Transcranial Magnetic Stimulation (TMS): 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.

Sham/Placebo

Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind

Transcranial Magnetic Stimulation (TMS): 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.

Open Cross Over High Frequency rTMS

Following 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)

repetitive transcranial magnetic stimulation: 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.

Total Total of all reporting groups

Baseline Measures
   High Frequency rTMS   Active High Frequency rTMS   Sham/Placebo   Open Cross Over High Frequency rTMS   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Improvement of Negative Symptoms (Positive and Negative Syndrome Scale [PANSS] Negative Symptoms Subscale) Relative to Pre-treatment Baseline.   [ Time Frame: At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits. ]

2.  Secondary:   Global Clinical Improvement   [ Time Frame: At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits. ]

3.  Secondary:   Social Functioning   [ Time Frame: At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits. ]

4.  Secondary:   Depression   [ Time Frame: At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits. ]

5.  Secondary:   Theory of Mind   [ Time Frame: At baseline and the end of each study phase (random and open) ]

6.  Secondary:   Smoking Behaviors   [ Time Frame: At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits. ]

7.  Secondary:   Cognitive Function   [ Time Frame: At baseline, the first and last rTMS sessions of each study phase (random and open), and at monthly follow-up visits. ]

8.  Secondary:   Cortical Excitability   [ Time Frame: At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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