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van CCT (UK)

van CCT (UK)

Feasibility of dual channel low field TMS for improvement of brain functioning.

- candidate number11163
- NTR NumberNTR3318
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-feb-2012
- Secondary IDs39489 ABR number
- Public TitleFeasibility of dual channel low field TMS for improvement of brain functioning.
- Scientific TitleFeasibility of dual channel low field TMS as a plasticity modulator: Pilot in healthy volunteers.
- ACRONYMDual low field TMS
- hypothesisUsing low field stimulation on two brain regions simultaneously, we aim to specifically alter the connectivity between one or more pairs of brain areas.
- Healt Condition(s) or Problem(s) studiedImpaired connectvity
- Inclusion criteria1. Adult healthy volunteers;
2. Native Dutch speaker;
3. Age 18-80.
- Exclusion criteria1. Psychiatric or neurological disease, present or past;
2. Visual or hearing limitations that can not be corrected for;
3. Alcohol or drug addiction;
4. Excessive intake of coffee (>10 units per day) or alcohol (>10 units per day);
5. Recent use of alcohol (within 1 day);
6. Recent use (within four weeks) of cannabis or any other non-prescription psychopharmaca;
7. Presence in the body of MRI-incompatible implants, electronic implants (e.g. cardiac pacemakers), or connectors of electronic equipment (e.g. electrodes);
8. Pregnancy, lactation.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 15-mrt-2012
- planned closingdate15-aug-2013
- Target number of participants70
- InterventionsTwo electromagnets are fitted over the EEG/NIRS cap. Magnetic field flux densities <5mT are applied to the head. The microTMS stimulus will consist of pulsed magnetic stimulation. Pulses will consist of random white noise (frequencies ranging from 0.3-100Hz) with a Gaussian envelope and will have a duration of 50 ms followed by 30 ms of rest. Before and after the stimulation the subjects will perform a cognitive task, during and before which EEG/NIRS will be recorded (active and resting conditions). These measurement are needed to determine the functional brain connectivity between two targeted brain areas.
- Primary outcome1. The change in effective brain connectivity estimated by DCM for EEG;
2. The differences in concentrations of oxygenated (HBo) and de-oxygenated blood before, during and after the treatment (as estimated from NIRS measurements).
- Secondary outcome1. The estimated coherence of EEG recordings between electrodes;
2. The ERP from EEg recordings;
3. The accuracy from the cognitive test;
4. The accuracy from the Digit symbol substitution test;
5. The differences in concentrations of oxygenated (HBo) and de-oxygenated blood before, during and after the treatment (as estimated from NIRS measurements).
- Timepoints1. Participants recruitment immediately after METC approved;
2. Measurements finalized as soon as enough participants are found;
3. Primary and secondary outcomes up to 6 months after the data were collected for the last subject.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Curcic-Blake Branislava
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryBrain connectivity, which refers to the anatomical and functional connections between different brain regions, is often pathologically altered in patients with psychiatric or neurological disorders such as epilepsy. Transcranial magnetic stimulation (TMS) is a tool to non-invasively modulate brain function. It is known that TMS can influence brain connectivity, but epilepsy is one of the prime contra-indications for TMS research. We intend to overcome this limitation by using a very weak form of TMS, largely developed and implemented in-house: microTMS. This is a proof of principle study is required before this technique can be tested on patients.
- Main changes (audit trail)
- RECORD20-feb-2012 - 10-mrt-2012

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