Trial Outcomes & Findings for The Use of Transcranial Electrical Stimulation for Hallucinations (NCT NCT02715765)
NCT ID: NCT02715765
Last Updated: 2020-10-26
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
At 1 week and 1 month post treatment.
Results posted on
2020-10-26
Participant Flow
The PI for this study has left the institution. After extensive effort to locate more information, only limited study data is available. 3 participants were enrolled, however no baseline data was collected/is available.
Participant milestones
| Measure |
Sham
The sham procedure involves only 40 sec direct current stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec.
Transcranial Sham Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. The sham procedure involves only 40 sec stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction
|
Active tDCS
Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). The current is held constant for 20 min. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.
Transcranial Direct Current Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA.
|
Active tRNS
Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). Once at 2mA, an alternating current of 2mA with a 0mA offset is applied at random frequencies over a range of 0.1 to 100 Hz. This is performed for 20 minutes. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.
Transcranial Random Noise Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sham
The sham procedure involves only 40 sec direct current stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec.
Transcranial Sham Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. The sham procedure involves only 40 sec stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction
|
Active tDCS
Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). The current is held constant for 20 min. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.
Transcranial Direct Current Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA.
|
Active tRNS
Current (2mA) is initiated in a ramp-like fashion over 10s from 0mA to 2mA using (SPONSTIM-25 25cm2 electrodes). Once at 2mA, an alternating current of 2mA with a 0mA offset is applied at random frequencies over a range of 0.1 to 100 Hz. This is performed for 20 minutes. Then the current is decreased in a ramp-like fashion over 10s from 2mA to 0mA.
Transcranial Random Noise Stimulation: Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA.
|
|---|---|---|---|
|
Overall Study
Study Termination
|
3
|
0
|
0
|
Baseline Characteristics
The Use of Transcranial Electrical Stimulation for Hallucinations
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: At 1 week and 1 month post treatment.Population: The PI for this study has left the institution. After extensive effort to locate more information, only limited study data is available. 3 participants were enrolled, however no baseline data was collected/is available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekPopulation: The PI for this study has left the institution. After extensive effort to locate more information, only limited study data is available. 3 participants were enrolled, however no baseline data was collected/is available.
Outcome measures
Outcome data not reported
Adverse Events
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active tRNS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place